U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
FORM 10-KSB
(Mark One)
[X] ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the fiscal year ended December 31, 2003
[ ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For the transition period from ___________ to ___________
Commission file number: 000-50095
Clinical Trials Assistance Corporation
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(Name of Small Business Issuer in its charter)
Nevada 27-0009939
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(State or other jurisdiction of (I.R.S. Employer Identification Number)
incorporation or organization)
2078 Redwood Crest, Vista, California 92081-7340
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(Address of principal executive offices) (zip code)
Issuer's telephone number: (760) 727-8448 Fax number: (760) 598-2611
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Securities registered under Section 12(b) of the Exchange Act:
Title of each class registered: None Name of each exchange on which
registered: None
Securities registered under Section 12(g) of the Exchange Act:
Common Stock, par value $.001
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(Title of class)
Check whether the issuer (1) filed all reports required to be filed
by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for
such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days.
Yes [X] No [ ]
Check if no disclosure of delinquent filers in response to Item 405
of Regulation S-B is contained in this form, and no disclosure will be
contained, to the best of registrant's knowledge, in definitive proxy or
information statements incorporated by reference in Part III of this Form
10-KSB or any amendment to this Form 10-KSB. [ ]
State issuer's revenues for its most recent fiscal year. $195,576
The issuer's stock is listed on the OTC-Bulletin Board; however the
issuer's stock has not traded.
As of March 22, 2004, the Issuer had 36,000,000 shares of common
stock issued and outstanding.
Documents incorporated by reference: See Item 13. Exhibits and Reports
on Form 8-K in Part III.
Transitional Small Business Disclosure Format (check one): Yes [ ] No [X]
1
Forward-Looking Statements
This report contains forward-looking statements. The forward-looking
statements include all statements that are not statements of historical
fact. The forward-looking statements are often identifiable by their use of
words such as "may," "expect," "believe," "anticipate," "intend," "could,"
"estimate," "continue," "plans" or the negative or other variations of
those or comparable terms. Our actual results could differ materially from
the anticipated results described in the forward-looking statements. Factors
that could affect our results include, but are not limited to, those
discussed in Item 6, "Management's Discussion and Analysis or Plan of
Operation" and included elsewhere in this report.
2
CONTENTS
PAGE
PART I
Item 1. Description of Business........................................4
Item 2. Description of Property.......................................19
Item 3. Legal Proceedings.............................................19
Item 4. Submission of Matters to a Vote of Security Holders...........19
PART II
Item 5. Market for Common Equity and Related Stockholder Matters......20
Item 6. Management's Discussion and Analysis or Plan of Operation.....21
Item 7. Financial Statements..........................................24
Item 8. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure........................25
Item 8A. Controls and Procedures.......................................25
PART III
Item 9. Directors, Executive Officers, Promoters and Control
Persons; Compliance with Section 16(a) of the
Exchange Act...............................................26
Item 10. Executive Compensation........................................28
Item 11. Security Ownership of Certain Beneficial Owners and
Management.................................................29
Item 12. Certain Relationships and Related Transactions................31
Item 13. Exhibits and Reports on Form 8-K..............................32
Item 14. Principal Accountant Fees and Services........................33
SIGNATURES ..............................................................34
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PART I
ITEM 1. DESCRIPTION OF BUSINESS.
A. BUSINESS DEVELOPMENT
(i) Business Development, Organization and Acquisition Activities
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Clinical Trials Assistance Corporation, a developmental stage company,
hereinafter referred to as ("the Company") or ("CTAL"), was organized by the
filing of Articles of Incorporation with the Secretary of State of the State
of Nevada on April 22, 2002. The original articles of the Company authorized
the issuance of twenty million (20,000,000) shares of Common Stock at par
value of $0.001 per share and five million (5,000,000) shares of Preferred
Stock at par value of $0.001. On April 30, 2002, the Company issued ten
million (10,000,000) shares of its $0.001 par value Common Stock for cash
of $10,000, held by one (1) shareholders of record. On March 5, 2004, at the
Company's annual shareholder meeting, the shareholders approved an increase
in authorized common shares to seventy million (70,000,000) at par value of
$0.001 per share.
On September 30, 2002, the Company completed a private offering of shares
of common stock of the Company pursuant to Regulation D, Rule 504 of the
Securities Act of 1933, as amended, which resulted in the sale of an
additional 2,000,000 shares of its $0.001 par value common stock to
approximately 40 shareholders. On March 5, 2004, at the Company"s annual
shareholder meeting, the shareholders approved a three-for-one forward
stock split. As of March 15, 2004, therefore, the number of common shares
issued and outstanding are thirty-six million (36,000,000).
The Company's president and CEO, Kamill Rohny, has been actively involved in
the pharmaceutical industry for the past thirty-two years. After his
retirement from Procter & Gamble Pharmaceuticals, he developed recruiting
methodologies for patient studies. This included the identification of
computer data bases to help research physicians find patients for their
investigative studies. This activity by Mr. Kamill Rohny does not constitute
any conflict with his past Procter & Gamble Pharmaceuticals employment.
Clinical Trials Assistance Corporation helps physician researchers recruit
appropriate patients to participate in specific clinical research trials
sponsored by the pharmaceutical industry. In helping the investigative sites
to recruit patients for clinical studies, by developing effective recruitment
programs, which enlist patients to participate in the early stages of these
studies, clinical recruitment companies help the pharmaceutical industry
shorten its development cycles and reduce the cost for evaluating new
pharmaceutical products. There are no assurances that the Company will be
able to recruit patients faster than its competition.
4
The Company's plan of operations for the next twelve months are to:
1. Identify clinical research centers who need the services of CTAL
to recruit patients. The success of the patient recruitment programs
will be measured by the amount dollars a physician researcher is willing
to spend versus the time and dollars spent to recruit patients for
clinical research trials.
2. Continue to identify successful financial success models to recruit
patients for clinical studies. During the past year, management
has expanded its operations into patient recruitment centers located in
27 different States. Management is seeking to expand its operations to
other investigative sites, such as, private practice physicians,
hospitals, major medical centers, health maintenance organizations,
pharmaceutical and biotechnology companies, all who conduct clinical
studies.
3. Seek strategic alliances of businesses that design clinical studies but
need assistance with patient recruitment. If appropriate opportunities
present themselves, the Company would consider acquiring businesses,
technologies, services or product(s) that the Company believes are
strategic to its operations.
If in the future, the Company should seek to raise additional capital it would
be accomplished via a private placement offering pursuant to Regulation D,
Rule 505 or 506. There is no guarantee that such financing will be available
to the Company, or if available, will be on terms and conditions satisfactory
to management.
(ii) Principal Products and Principal Markets
Clinical Trials Assistance Corporation helps physician researchers find patients
for ongoing clinical studies. These clinical trials would be conducted in a
physician's office, hospital setting, or private clinic, who have separately
contracted with a major pharmaceutical Company or U.S. Government agency to test
developmental pharmaceutical products, which have been approved by the Food and
Drug Administration ("FDA") for testing in humans. In some cases, the
pharmaceutical companies themselves conduct clinical research studies. The
Company plans to solely focus on patient recruitment for these clinical studies.
Said differently, the Company helps these researchers find patients for on-going
studies. The researchers screen and evaluate whether these patients qualify for
these studies. The Company, at this time, does not involve itself with data
analysis, regulatory services, quality assurance and other consultation
services. The actual clinical trials are performed at the investigative sites
as approved by the FDA. The Company's business is currently focused on the U.S.
markets.
Management believes the Company's services to the investigative sites would
allow them to build and maintain successful clinical research businesses.
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Patient Recruitment
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CTAL has developed a series of patient recruitment tools for the investigative
sites. These tools include: an 1-800 phone number for patients to obtain
information and schedule an appointment, newspaper ads, direct mail, MD office
flyers, MD to MD letters, MD to patient letters and senior centers. To date,
the Company's best success in developing patient recruitment tools has been
with first class pre-sorted postcard directed to specific age groups in
targeted geographic locations.
Business Strategy
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The Company's business plans encompass the following strategies:
o Market its services to physicians who conduct research projects.
The clientele includes investigative sites, such as, private
practice physicians, hospitals, major medical centers, health
maintenance organizations, pharmaceutical and biotechnology
companies, all who conduct clinical studies.
o Identify physician researchers and offer the services of patient
recruitment for these studies.
o Based on the type of studies performed, such as targeted age group
or specific illness, management has identified specific patient
data base to target. The database includes renting, reassembling,
and combining names and addresses and sorting by age group and gender
to determine who is most likely to suffer from a particular disease
state. The Company rents mailing labels from brokers who specialize
collecting this type of demographic data. These mailing labels are
rented on a Quarterly basis, when the Company undertakes a specific
recruitment program. There is no way of knowing, who has a
particular disease state to target; therefore, a mass population is
targeted to receive a mailer, which invites them to participate in
a study. Patients who participate in a clinical study receive: a
study related physician exam, laboratory tests, free medication, and
often times travel expenses and nominal fees to entice them to
participate.
o Utilize known networking groups, e.g., senior centers, churches,
social clubs, ethnic groups, who conduct regular meetings among their
members. to recruit these patients. These groups consists of people
who talk among themselves to give the studies a word-of mouth
endorsement, where the recommend that their friends are evaluated
for the study. CTAL utilizes these groups by scheduling the
investigative physician(s), as guest speakers, for their regular
scheduled meetings. This gives the audience an opportunity to determine
whether or not they wish to participate in the study, by meeting the
investigative physician who will be conducting the study.
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o Advertise for patients utilizing newspapers to recruit these patients.
o Schedule these subject patients with the physician researchers as
candidates to be evaluated for their studies.
o Establish a reputation for Clinical Trials Assistance Corporation as
a premier patient recruitment company.
(iii) Status of Products and Services
The Company originally established a business development program with Eugene
Boling, MD, a Rheumatologist at Boling Clinical Trials, located at 8263 Grove
Avenue, Suite 100, Rancho Cucamonga, CA 91730. Boling Clinical Trials is one
of the larger patient research centers in Southern California. This is
measured by the number of patients enrolled in their clinical trials. This
was shared with Dr. Boling by the sponsoring pharmaceutical companies who are
conducting these studies. They can conduct as many has sixteen different
patients studies at the same time. Each study seeks to enroll anywhere from
24 to 60 patients, on average. Boling Clinical Trials is situated in an area
of Southern California with a surrounding population of 500-600,000 inhabitants.
CTAL has participated in recruiting patients for two separate studies at Boling
Clinical Trails, and the Company is in process of recruiting patients two
additional patient studies for Boling Clinical Trials. The clinical studies
included recruitment for an osteoporosis study and a rheumatoid arthritis study.
The Company's best results in the recruitment of patients for these two studies
came from a targeted mail program directed to an older age group, in zip codes
adjacent to Boling Clinical Trials.
The Company has developed a variety of different postcard recruitment
initiatives, an example includes:
a) The mailing of ten thousand postcards per month for a three month
period, or a total of 30,000 postcards. This program generates
approximately 100 patients who call schedule an initial screening with
the investigative site. Approximately 9 patients are qualified for
the study, and approximately 6 patients were ultimately enrolled in a
clinical trial during a three month period.
b) The second initiative is a scaled-up version of the first initiative.
It consists of a mailing of thirty thousand postcard mailings, per month,
over a three month period, or a total of 90,000 postcards. This program
generates approximately 450 patients who call schedule an initial
screening with the investigative site. Approximately, 27 patients are
qualified for the study, and approximately 18 patients were ultimately
enrolled in a clinical trial during a three month period.
Based on the results of these two examples, the end results per enrolled patient
were proportionally the same based on the size of the mailing. Based on CTAL's
year 2003 experience, the Company has duplicated these results throughout the
country at 23 different locations.
7
Since CTAL has begun its recruiting activities, the average cost to recruit
patients has been $1,475 -$2,000 per enrolled patient. This cost is based a
targeted postcard mail program directed to an older age group, in specific zip
codes. The data is based on a three month postcard mailing program of 30,000
mailings per month for a total of 90,000 mailings. The results of this
postcard program has enrolled, on average, six (6) patients per month at a
cost of $8,850 $12,000 per month.
The Pharmaceutical Industry
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Currently, only an estimated 10-12% of the 50 millions individuals in the U.S.
who have chronic illnesses participate in clinical trials, which means that 90%
of eligible patients are not entering clinical trials (Source: CenterWatch).
According to CenterWatch, the pharmaceutical industry spent more than $30
billion in research and development in 1999 alone, with almost 40% earmarked
for clinical development. Spending in this area is growing by an estimated
13% annually.
Before a new pharmaceutical or biotechnology product can be marketed in the
United States, it must undergo extensive testing and regulatory review to
determine its relative safety and effectiveness. Companies seeking approval
of these products are responsible for performing and analyzing the results
of preclinical and multi-phase clinical trials. Preclinical trials can last
years and involve animal testing and laboratory analysis to determine the
basic biological activity and safety of the product. Upon successful
completion of the preclinical phase, the product undergoes a series of
clinical tests in humans, this includes healthy volunteers as well as
patients with the specific disease. Clinical trials generally take longer
to perform than preclinical trials, typically lasting five to seven years.
In the United States, preclinical and clinical testing must comply with the
requirements of Good Clinical Practices and other standards promulgated by
the Food and Drug Administration, or the FDA, and other federal and state
governmental authorities. The FDA defines Good Clinical Practices as "a
standard for the design, conduct, performance, monitoring, auditing,
recording, analyses, and reporting of clinical trials that provides
assurance that the data and reported results are credible and accurate and
that the rights, integrity, and confidentiality of trial subjects are
protected."
According to clinical trials data provided by the National Institutes of Health
website, at www.clinicaltrials.gov, they list approximately 7,000 on-going
clinical studies, with approximate enrollment of 200 patients per study. These
clinical studies are sponsored by the National Institutes of Health, other
federal agencies, and the pharmaceutical industry.
8
Clinical trials often represent the most expensive and time-consuming part
of the overall drug development process. The information generated during
these trials is critical for gaining marketing approval from the FDA or other
regulatory agencies. After the successful completion of Phase III trials, the
sponsor of a new drug must submit a New Drug Application ("NDA") to the FDA.
The NDA is a comprehensive filing that includes, among other things, the
results of all preclinical and clinical studies, information about the drug's
composition and the sponsor's plans for producing, packaging and labeling the
drug. Most of the clinical data contained in an NDA is generated during the
Phase II and III trials. The FDA's review of an NDA can last from several
months to several years, with the average review lasting two years. Drugs that
successfully complete this review may be marketed in the United States, subject
to the conditions imposed by the FDA in its approval.
Pharmaceutical and biotechnology companies face increased pressure to bring
new drugs to market in the shortest possible time, thereby reducing costs,
maintaining market share and accelerating realization of revenue. Currently,
total development of a new drug takes approximately eight to twelve years, a
significant portion of a drug's twenty year period for protection under
United States patent laws. Certain pharmaceutical companies have initiated
plans to reduce this time to approximately five to seven years. Pharmaceutical
and biotechnology companies are attempting to increase the speed of new product
development, and thereby maximize the period of marketing exclusivity and
economic returns for their products, by outsourcing development activities.
The clinical research process generally has been inefficient and costly for
sponsors, requiring the expenditure of considerable resources and efforts
associated with study start-up, meeting enrollment quotas and collecting
complete and consistent data. Historically, sponsors have had to identify
and negotiate contracts and study budgets with numerous geographically
dispersed clinical research investigators, a process which impedes quick
study start-up. These clinical trials are generally reviewed and approved
by an independent institutional review board ("IRB") for each research site
participating in a study. There is a separate IRB for each ongoing clinical
trial.
The IRB has been established to assure the protection of all human subjects
in research projects. In accordance with U. S. Department of Health and Human
Services Regulations for Protection of Human Subjects (45 CFR 46), an
institutional review board committee, composed of members from a variety of
scientific disciplines as well as community members, assists investigators in
the protection of the rights and welfare of human subjects. The IRB also
serves to facilitate valuable human subject research as well as protect the
investigator and the institution through a comprehensive review process. All
human research projects must be reviewed and approved by the IRB prior to
initiation and then conducted in full compliance with the IRB guidelines
established by U. S. Department of Health and Human Services.
9
The clinical research industry is driven by the need of the pharmaceutical
and biotechnology companies to produce new drugs at low costs while at the
same time maintaining compliance with governmental regulations principally
imposed by the FDA. Competition and the increasing pressure to control
costs are forcing pharmaceutical and biotechnology companies to become more
efficient in developing new drugs. The pharmaceutical and biotechnology
companies are actively seeking improved ways to save time in the clinical
development process in order to bring products to market faster. The benefit
in bringing their products to the market faster, helps these companies
recover their research and development costs and achieve higher prices on
their patented products before they lose their patent protection and
generics enter the market. In an effort to save time and cut costs,
physician researchers are outsourcing certain aspects of the clinical
research process to third parties, including research networks.
The services Clinical Trials Assistance Corporation plans to provide are
subject to federal regulations pursuant to IRB review. For example, the
Company's brochures and advertisements to recruit patients are subject
to a Independent Board Review and subsequent approval from the physician
researchers. The IRB is required to apply institutional rules, federal, state
laws and regulation in reviewing study protocols, evaluating risks and benefits,
ensuring the selection of subjects is equitable, monitoring the data collected
to ensure the safety of subjects, protecting the privacy of subjects and to
maintain the confidentiality of files. During their regularly scheduled board
meetings, they also review and approve brochures and advertisements to ensure
compliance with the study protocol.
Investigative Sites
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The investigative site industry includes all of the clinical investigators
who enroll patients in clinical trials and collect information at the patient
level for pharmaceutical and biotechnology companies and Contract Research
Organizations ("CRO"). The investigative site industry is facing significant
cost reduction pressures as a result of the pressures on pharmaceutical and
biotechnology companies to reduce costs and the amount of time required to
bring a drug to market. As a result of increased pressures, pharmaceutical
and biotechnology companies who need to conduct clinical research have reduced
their use of academic medical centers for clinical studies and have increased
their use of private practice research sites. In many instances, private
practice physician sites can provide greater access to patients and the
ability to conduct trials more rapidly and efficiently than academia. In
addition, participation in clinical trials by private physicians has increased
as healthcare providers discover that they are able to offer patients access
to more advanced therapies and the opportunity to receive free or reduced-cost
medical care.
10
CTAL plans to assist the investigative sites, with planning and coordinating
the patient recruitment of independent clinical trials on drugs for
pharmaceutical and biotechnology companies. By assisting these investigative
sites in patient recruitment, and helping them identify and enroll patients
in the early stages of their clinical studies, the Company plans to facilitate
faster study start-up. It is not uncommon for an investigate site to undertake
a clinical study project, and not begin their patient recruitment efforts for
six months after the study is scheduled to begin. CTAL by assisting physician
researches in recruiting patients for their studies, at the outset of the
study, plans to help will be helping the pharmaceutical and biotechnology
companies conducting clinical trials to complete the clinical research process
efficiently and cost effectively, by saving them time in completing these
studies. According to Advanced Clinical Software, advertising effectiveness
for one site, using a variety of media sources (radio, TV, newspaper, internet)
can range from $500 to $2,500 cost per enrolled randomized patient.
The investigative sites typically perform the clinical trials, focusing on
Phases II through IV of the drug development process. The clinical
research portion of the drug development process involves selection of
investigative sites to conduct the trials. The physician researchers are
responsible for the actual conduct of the trials and the gathering and
completion of the data generated during the trials. CTAL solely assists these
sites by helping them find patients, who are subsequently screen by these
physician recruiters who are in the process of conducting research studies.
The physician researchers are responsible to determine whether or not these
patients should be enrolled in their studies, based on the criteria of the
study protocols.
In conducting these studies, the investigative sites administer medical
evaluations, healthcare procedures and study medications to patients in
accordance with the protocol under the direction of a qualified principal
investigator. A "qualified principal investigator" has been approved by both
the FDA and sponsoring pharmaceutical/biotechnology company to conduct
human clinical trials.
A "qualified principal investigator" requires sufficient knowledge, scientific
training, a medical degree and accreditation as evidenced by their credentials,
to conduct clinical studies to investigate the effectiveness and in-use safety
of investigational products in conducting clinical trials on human patients.
The qualified principal investigator needs to be familiar with the background
and requirement of the study before taking receipt of the investigational
product. The qualified principal investigator is responsible for all aspects
of the conduct of the study. This would include: the dispensing and the
administration of the investigational product(s), the implementation of the
study protocol, the collection and reporting of the study data and the
protection of the health and welfare of the personnel and patients involved in
the study. The qualified principal investigator is employed by the sponsor or
a contract research organization. The investigator may be assisted by trained
technical assistants in collecting, recording and the subsequent processing of
data.
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Clinical Trials Assistance Corporation plans to focus it patient recruitment
activities with investigative sites that are owned by private practice
physicians. The size of the private physician practices range from one
physician to approximately twenty physicians. Typically, management expects
the investigative sites in its network will consist of two to four partners
in a private practice medical office.
Marketing Strategies
--------------------
CTAL assists pharmaceutical and biotechnology companies in developing and
implementing patient recruitment programs to speed completion of their
research studies. CTAL services include the development and implementation
of advertising programs, public service announcements and other tools to
assist sites in finding and enrolling suitable patients into studies.
These include, but not limited to newspaper, senior centers, churches,
social clubs, and ethnic groups. The Company is investigating the
utilization and subcontracting of a phone room as a tool to help the
clinical investigators screen patients and set appointments. The
management and training of the phone room staff would be the
responsibility of the clinical investigators. The Company would help
them identify a phone room to outsource these services. The purpose
of the phone room is to hire and train an 24-hour answering service to
screen patients and answer basic questions about the clinical study.
They would subsequently set an appointment for the patient to come into
the office for further evaluation. This service would relieve the
investigators staff in screening these initial calls. It was initially
discovered that where investigate offices are understaffed, phone calls
were unanswered and potential study patients did not pursue enrolling in
a clinical study.
The Company also contacts known physicians who participate in medical
studies and pharmaceutical companies who wish to conduct a pharmaceutical
study. The Company markets its services to specific physicians who
specialize in conducting clinical trials with these known disease states,
e.g., arthritis, osteoporosis, hypertension, and diabetes.
The industry is highly fragmented with many small, limited-service providers
as well as in-house research departments, universities and teaching hospitals,
have substantially greater resources than the Company. However, the Company
believes it has an opportunity to take advantage of the trend toward
outsourcing. Physicians who conduct clinical trials do not have the time or
staff to recruit patients for their studies. They are busy with their own
medical practices and qualifying patients for the clinical studies. They
prefer to outsource the patient recruitment job to a third party. The
Company's strategy is to help facilitate patent enrollment in these
preclinical trials.
CTAL markets its patient recruitment services to investigative sites,
so that the physicians at these sites are not encumbered in devoting a greater
percentage of their time in recruiting patients versus attending to their own
practice.
12
The Company's success is dependent upon its ability to attract and retain high
quality investigative sites and recruit patients for their active studies.
Competition
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The clinical research industry is highly fragmented. The Company primarily
competes with Clinical Research Organizations, other patient recruitment
organizations and private practice research sites who are competing to
recruit the same patients for a particular clinical study. The majority of
these private practice research sites are single sites. CTAL also competes
with hospitals and academic medical centers and site management organizations
("SMO"), who recruit patients for their clinical studies. No single
competitor or group of competitors has a substantial presence in the recruitment
of patients for clinical trials. All of the Company's competitors, who recruit
patients, have greater financial resources and name recognition, greater
experience in specific diseases and conditions and larger medical specialist
networks than Clinical Trials Assistance Corporation.
CTAL has little experience in competing favorably in most of these areas,
there are no assurances that the Company will be able to respond to these
pressures or changes. Further, there are no significant barriers to entry
into the recruitment of patients for clinical trials. A better funded company
with knowledge of the industry could capture any potential business from CTAL.
(iv) Risk Factors
a) LIMITED OPERATING HISTORY AND DEVELOPMENT PERIOD MAKES POTENTIAL
DIFFICULT TO ASSESS.
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The Company was incorporated in the State of Nevada on April 22, 2002 (Nevada
File Number: C9967-20). As of the date of this document, the Company has
developed a business plan, established administrative offices and an operating
facility in Vista, California and begun the process of testing its model
for recruiting patients for human pharmaceutical research studies. During the
development period, the company hopes to evaluate methodologies to recruit
patients in a timely, cost effective basis for investigative clinical
research centers. There are no assurances the company will be able to identify
efficient and cost effective methodologies to recruit patients during this
development period. Failure to find effective patient recruitment
methodologies can have an adverse effect on the Company's future.
The Company has limited operating history and must be considered to be
a developmental stage company. Prospective investors should be aware of the
difficulties encountered by such new enterprises, as the Company faces all of
the risks inherent in any new business and especially with a developmental
stage company. The likelihood of success of the Company must be considered
in light of these problems, expenses that are frequently incurred in the
operation of a new business and the competitive environment in which the
Company will operate.
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b) ISSUANCE OF STOCK TO FUND THE COMPANY MAY DILUTE YOUR INVESTMENT AND
REDUCE YOUR EQUITY INTEREST IN THE COMPANY.
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It is likely that the Company will issue additional shares of common stock or
preferred stock to expand operations. The proceeds of any offering will
be used for the operations of the business. This would include, but not
limited to hiring additional personnel, upgrading demographic data bases, and
the development of marketing materials to attract new business. The
consequences may be a significant dilution to shareholders' investment, and a
material decrease in shareholders' equity interest in the company. Since CTAL
has not made any determination with respect to new equity funding, management
cannot speculate on the amount of securities which CTAL might issue. At its
sole discretion, the board of directors may issue additional company
securities without seeking shareholder approval. These future offerings could
significantly dilute the value of any previous investor's investment value.
c) COMPANY MAY FAIL TO CONVINCE ENOUGH CUSTOMERS TO USE ITS SERVICES.
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The Company's has established a patient recruitment business throughout the
U.S. Despite contacts and a referral base from the Company's management, if
CTAL cannot establish itself as an effective business, CTAL will not be able
to expand its business base. There can be no assurances that its market
acceptance will be forthcoming.
d) THE COMPANY IS DEPENDENT ON ONE KEY OFFICER TO DEVELOP AND IMPLEMENT ITS
BUSINESS PLAN.
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The Company plans to rely heavily on the expertise from its sole officer,
Mr. Kamill Rohny, who has knowledge of the pharmaceutical industry. Should
the Company be deprived of the services of its sole officer for any reason
during this period of initial and expansion, the results would be devastating
to the Company and could lead to its dissolution. Although this sole officer
has had experience in helping physician researchers in the past recruit
patients, he cannot be sure that this business model will be successful in
other markets. For example, the Company may be unable to train other personnel
on how to develop another market to recruit patients for clinical studies.
Future operating results would be adversely affected if the Company is unable
to expand its operations. The Company does not have an employment agreement
with Mr. Rohny and Mr. Rohny is engaged in other business activities which
may detract his attention from the Company.
14
e) PATIENT RECRUITMENT MAY INFRINGE ON PRIVACY CONCERNS.
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The Company collects and utilizes data derived from various sources to recruit
patients for clinical studies. The Company has access to names and addresses
of potential patients who may participate in these studies. This subjects the
Company to knowledge of what studies are taking place, and who may be
participating in these studies. In order to deliver a targeted mail program,
the Company compiles specific demographic information. This information needs
to be protected to circumvent privacy concerns. The information keyed to a
specific disease state could inadvertently fall into the wrong hands without
the consent of the patient.
Due to privacy concerns, the company must take steps to ensure patient lists
remain confidential. There can be no assurance that any protection will be
available for such data or that others will not claim rights to such data.
f) GOVERNMENT REGULATION COULD UNDERMINE THE COMPANY'S PROFITABILITY.
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Though the Company plans on obtaining all required federal and state
permits, licenses, and bonds to operate its facilities, there can be no
assurance that the Company's operation and profitability will not be subject
to more restrictive regulation. The services Clinical Trials Assistance
Corporation provides are subject to various federal regulations.
For example, its brochures and advertisements to recruit patients are subject
to a Independent Board Review and subsequent approval from the physician
researchers.
g) SHARES SUBJECT TO RULE 144, IF SOLD COULD HAVE A MATERIAL NEGATIVE
IMPACT UPON THE MARKET PRICE OF THE COMPANY'S SHARES.
------------------------------------------------------------------
On March 22, 2004, the Company had 30,000,000 Common Shares issued and
outstanding that have not been registered with the Commission or any State
securities agency and which are currently restricted pursuant to Rule 144
promulgated by the Commission under the 1933 Act. Rule 144 provides, in
essence, that a person holding restricted securities for one year from the
date the securities were purchased from the issuer, or an affiliate of the
issuer, and fully paid, may sell limited quantities of the securities to the
public without registration, provided there shall be certain public
information with respect to the issuer. Pursuant to Rule 144, securities
held by non-affiliates for more than three years may generally be sold
without reference to the current public information or broker transaction
requirements, or the volume limitations. None of the current outstanding
restricted shares are available for resale pursuant to Rule 144. The sale of
some or all of the currently restricted Common Shares could have a material
negative impact upon the market price of the Common Shares if a market for
the Common Shares should develop in the future. (See "PRINCIPAL STOCKHOLDERS")
15
h) RISKS ASSOCIATED WITH ACQUISITIONS MAY NOT BENEFIT THE COMPANY AND
DILUTE THE VALUE OF THE COMPANY'S SHARES.
-------------------------------------------------------------------
If appropriate opportunities present themselves, the Company would acquire
businesses, technologies, or service(s) that the Company believes are
strategic and would help it to expand its operations and/or future customer
base. There can be no assurance that the Company will be able to identify,
negotiate or finance future acquisitions successfully, or to integrate such
acquisitions with its current business. The process of integrating an
acquired business, technology, service or product(s) into the Company may
result in unforeseen operating difficulties and expenditures and may absorb
significant management attention that would otherwise be available for ongoing
development of the Company's business. Further, there can be no assurance
that the anticipated benefits of any acquisition will be realized.
Future acquisitions could result in potentially dilutive issuances of equity
securities, the incurrence of debt, contingent liabilities and/or amortization
expenses related to goodwill and other intangible assets, which could
materially adversely affect the Company's business, results of operations and
financial condition. Any future acquisitions of other businesses, technologies,
services or product(s) might require the Company to obtain additional equity or
debt financing, which might not be available on terms favorable to the Company,
or at all, and such financing, if available, might be dilutive.
i) LOW-PRICED STOCKS MAY AFFECT THE RESELL THE COMPANY'S SHARES.
-------------------------------------------------------------
Although the Company's stock is listed on the OTC-Bulletin Board, as of
March 22, 2004, no shares have traded. If someone where to purchase the stock,
the purchasers of the shares may have difficulty selling their common stock
should they desire to do so. Penny Stock Regulation Broker-dealer practices in
connection with transactions in "Penny Stocks" are regulated by certain penny
stock rules adopted by the Securities and Exchange Commission. Penny stocks
generally are equity securities with a price of less than $5.00 (other than
securities registered on certain national securities exchanges or quoted on the
NASDAQ system). The penny stock rules require a broker-dealer, prior to a
transaction in a penny stock not otherwise exempt from the rules, to deliver a
standardized risk disclosure document that provides information about penny
stocks and the risk associated with the penny stock market. The broker-dealer
must also provide the customer with current bid and offer quotations for the
penny stock, the compensation of the broker-dealer and its salesperson in the
transaction, and monthly account statements showing the market value of each
penny stock held in the customer's account. In addition, the penny stock rules
generally require that prior to a transaction in a penny stock, the broker-
dealer must make a written determination that the penny stock is a suitable
investment for the purchaser and receive the purchaser's written agreement to
the transaction. These disclosure requirements may have the effect of reducing
the level of trading activity in the secondary market for a stock that becomes
subject to the penny stock rules. When the Registration Statement becomes
effective and the Company's securities become registered, the stock will likely
have a trading price of less than $5.00 per share and will not be traded on any
exchanges.
16
j) RISKS ASSOCIATED WITH INFRINGEMENT OF INTELLECTUAL PROPERTY.
------------------------------------------------------------
The Company is subject to intellectual property infringement from its
competition. Likewise, the competitors in the industry, hold their recruiting
methods highly confidential. The more widely the Company employs any methods
which are successful, the more likely these methods become vulnerable to
duplication by other recruiting centers. The are no assurances that the
Company will be able to protect, even if it copyrights its recruiting
methodologies, from the competition.
(v) Customers
The Company has established a customer base of physician researchers and
six pharmaceutical companies. There are no assurances that the Company will
be able to offer its services that would attract future customers from its
competition.
(vi) Patents, Trademarks, Licenses, Franchises, Concessions, Royalty
Agreements, or Labor Contracts
The Company regards substantial elements of its future and underlying
infrastructure and technology as proprietary and attempts to protect them
by relying on trademark, service mark, copyright and trade secret laws and
restrictions on disclosure and transferring title and other methods. This
would include the methodologies the Company develops to recruit patients for
clinical studies. The Company plans to enter into confidentiality agreements
with its future physician researchers and employees. Despite these precautions,
it may be possible for a third party to copy or otherwise obtain and use the
Company's proprietary information without authorization or to develop similar
technology independently. Legal standards relating to the validity,
enforceability and scope of protection of certain proprietary rights in the
clinical trials business may be uncertain, and no assurance can be given as
to the future viability or value of any of the Company's proprietary rights.
This can be no assurance that the steps taken by the Company will prevent
misappropriation or infringement of its proprietary information, which could
have a material adverse effect on the Company's business, results of operations
and financial condition.
(vii) Impact on Environmental Laws
-----------------------------------
As the Company is involved in recruiting patients for clinical trials, it does
not expect to have any impact on environmental laws.
17
(viii) Employees
----------------
The Company currently has one (1) employee, who serves as President and Chief
Executive Officer. Management out-sources all printing and mailing activities.
In order to further implement its business plan, management recognizes that
additional staff will be required. This would include clerical personnel, and
a marketing staff as required to complete the work. No assurances can be given
that the Company will be able to find suitable employees that can support the
future needs of the Company or that these employees can be hired on terms
favorable to the Company.
(a) The Company's performance is substantially dependent on the performance
of its President, Kamill Rohny.
(b) The Company does not carry key person life insurance on any of its
personnel. The loss of the services of its executive officers could have a
material adverse effect on the business, results of operations and financial
condition of the Company. The Company's future success also depends on its
eventual ability to attract and retain highly qualified technical and
managerial personnel.
(c) There can be no assurance that in the future the Company will be able
to attract and retain additional highly qualified technical and managerial
personnel. The inability to attract and retain the technical and managerial
personnel necessary to support the growth of the Company's business, due to,
among other things, a large increase in the wages demanded by such personnel,
could have a material adverse effect upon the Company's business, results of
operations and financial condition.
(ix) Present Licensing Status
-----------------------------
The Company is currently incorporated in Nevada and registered with the State
of California to conduct business in the State. Additionally, the Company has
a business license (No. BL012608) to engage and conduct business in Vista, CA.
18
ITEM 2. DESCRIPTION OF PROPERTY.
The Company's administrative offices/corporate headquarters and operating
facility are located at: 2078 Redwood Crest, Vista, California 92081-7340.
Telephone number: (760) 727-8448. An officer of the Company provides the
Company with office space. The estimated fair market value of the office
space is valued at $1,000 per month.
Investment Policies
The Company does not currently own and the Company has not made any
investments in real estate, including real estate mortgages, and the
Company does not intend to make such investments in the near future.
ITEM 3. LEGAL PROCEEDINGS.
As of the date hereof, Clinical Trials Assistance Corporation is not a party
to any material legal proceedings, and none are known to be contemplated
against it.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
The Registrant held its annual shareholder meeting on March 5, 2004.
At this meeting the shareholders voted and approved the following
proposals:
1. To increase the number of the Company's authorized Common Shares,
from twenty million (20,000,000) to seventy million (70,000,000) shares;
2. Election of two Directors (Kamill Rohny and Eugene P. Boling, MD);
3 Forward Split the Common Stock three-for-one;
4. Approval to issue warrants to purchase up to 1,800,000 shares of
the Company's Common Stock;
5. Ratification of Beckstead and Watts, LLP as independent auditors.
19
PART II
ITEM 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS.
(i) Market Information
----------------------
The Company's Common Stock is traded on the OTC Bulletin Board under the
symbol "CTAL." A limited market exists for the trading of the Company's
common stock. There has been no trading activity in the Common Stock.
There are no assurances any trading activity will take place in the future
for the Company's Common Stock.
At the Company's annual shareholder meeting, held on March 5, 2004, the
shareholders approved a resolution to issue warrants to purchase up
to 1,800,000 shares of Common Stock, which warrants may be accompanied by
other securities or may not be accompanied by other securities of the Company.
The Company did not repurchase any of its shares during the calendar year
covered by this report.
(ii) Holders
------------
The approximate number of holders of record of common stock as of March 15,
2004 was approximately forty (40).
(iii) Dividends
---------------
Holders of common stock are entitled to receive such dividends as the board of
directors may from time to time declare out of funds legally available for the
payment of dividends. No dividends have been paid on our common stock, and we
do not anticipate paying any dividends on our common stock in the foreseeable
future.
(iv) Liquidity and Capital Resources
-------------------------------------
On April 30, 2002, the Company issued ten million (10,000,000) shares of
its $0.001 par value Common Stock for cash of $10,000, purchased by Mr.
Kamill Rohny, President and founder of the Company.
On September 30, 2002, Clinical Trials completed a private offering of shares
of our common stock pursuant to Regulation D, Rule 504 of the Securities Act of
1933, as amended, and the registration by qualification of said offering in the
State of Nevada, whereby Clinical Trials sold 2,000,000 shares of Common Stock
to unaffiliated shareholders of record, none of whom were or are officers,
directors or affiliates of the Company.
20
The Company does not have any preliminary agreements or understandings
between the company and its stockholders/officers and directors with
respect to loans or financing to operate the company. The Company
currently has no arrangements or commitments for accounts and accounts
receivable financing.
The Company has no current commitments or other long-term debt. Additionally,
the Company has and may in the future invest in short-term investments from
time to time. There can be no assurance that these investments will result in
profit or loss.
ITEM 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION.
General
-------
A. Management's Plan of Operation
(i) For the calendar year ended December 31, 2003, the Company generated
revenues of $195,576 and generated a net profit of $32,310. Cost of sales
represented 23% of gross revenues. As of December 31, 2003 Clinical Trials
Assistance Corporation has $62,619 in available cash and no liabilities to
continue its operations.
The Company has developed a methodology to recruit patients for clinical
studies. This methodology begins with patient recruitment for a particular
study at one research center. Upon validation that patients are recruited for
this particular study, CTAL recruits patients nationwide at other medical
centers where the same study is taking place. There are no assurances CTAL can
duplicate these results for similar studies conducted by different investigative
centers. Management believes it can currently handle a work capacity of ten
studies per year. Based on the costs of advertising, developing data bases,
and mailing flyers to these data bases, management expects its hard costs of
services to represent approximately thirty percent of revenues generated.
The major components to expenses faced by the company in its day to day
operations includes auditor fees, legal fees, developing databases of potential
patients, based on demographic information, and general administrative expenses.
If the Company becomes profitable, the company will access salaries and
adding additional personnel to the payroll. Management intends to continue
minimize costs until such a time in its discretion it believes expansion would
be prudent. One element in making this determination is positive cash flow on
a quarterly basis.
On December 15, 2003, the directors of the Company (Kamill Rohny and Eugene
Boling, MD) carried out an evaluation of the effectiveness of the on-going pilot
studies to-date. They concluded that Boling Clinical Trials needs to continue
and possibly increase their spending with CTAL.
21
Management believes that it has sufficient liquidity and cash reserves for
the next 12 months. The Company is currently conducting a patient recruitment
program for two major clinical studies. Based on the results of these
programs, the Company may be offered to perform patient recruitment on a
national basis for these two clinical studies.
The Company does not have any preliminary agreements or understandings
between the company and its stockholders/officers and directors with
respect to loans or financing to operate the company. The Company
currently has no arrangements or commitments for accounts and accounts
receivable financing. There can be no assurance that any such financing
can be obtained or, if obtained, that it will be on reasonable terms.
There remains no guarantees that other companies might not be working on
similar patient recruitment methodologies and that some of these competitive
companies may have better funding or more workable business plans.
(ii) Management believes that the Company's future growth and success
will be largely dependent on its ability to find physician researchers who
need help in recruiting patients for their clinical studies.
(iii) The Company does not expect to purchase or sell any of its
facilities or equipment.
Clinical Trials has only one business segment, therefore, no table showing
percentage breakdown of revenue by business segment or product line is
included.
Results of Operations
---------------------
For the year ended December 31, 2003, the Company generated $195,576 in revenues
versus $7,200 for the same period last year. Cost of sales for the year ended
December 31, 2003 was $45,476 or 23% of revenues. It should be noted that the
Company was first incorporated on April 22, 2002, and during the calendar year
2002, the Company was field testing its recruitment programs. For year ended,
the Company had revenues of $195,597 and generated a net profit of $32,310. The
bulk of the Company's expenses included general and administrative expenses of
103,390. The majority of these expenses were related to start-up costs.
22
Plan of Operation
-----------------
The Company's plan of operations includes:
1. Identify clinical research centers who need the services of CTAL
to recruit patients. The success of the patient recruitment programs
will be measured by the amount dollars a physician researcher is willing
to spend versus the time and dollars spent to recruit patients for
clinical research trials.
2. Continue to identify successful financial success models to recruit
patients for clinical studies. During the past year, management
has expanded its operations into patient recruitment centers located in
27 different States. Management is seeking to expand its operations to
other investigative sites, such as, private practice physicians,
hospitals, major medical centers, health maintenance organizations,
pharmaceutical and biotechnology companies, all who conduct clinical
studies.
3. Seek strategic alliances of businesses that design clinical studies but
need assistance with patient recruitment. If appropriate opportunities
present themselves, the Company would consider acquiring businesses,
technologies, services or product(s) that the Company believes are
strategic to its operations.
23
ITEM 7. FINANCIAL STATEMENTS.
CLINICAL TRIALS ASSISTANCE CORPORATION
(A Development Stage Company)
FINANCIAL STATEMENTS
DECEMBER 31, 2003 AND 2002
CONTENTS
--------
CONTENTS
PAGE
INDEPENDENT AUDITORS' REPORT F-1
BALANCE SHEETS F-2
STATEMENTS OF OPERATIONS F-3
STATEMENT OF STOCKHOLDER'S DEFICIT F-4
STATEMENTS OF CASH FLOWS F-5
NOTES TO FINANCIAL STATEMENTS F-6-12
24
BECKSTEAD AND WATTS, LLP
----------------------------
CERTIFIED PUBLIC ACCOUNTANTS
3340 Wynn Road, Suite B
Las Vegas, NV 89102
702.257.1984
702.362.0540 (fax)
INDEPENDENT AUDITORS' REPORT
Board of Directors
Clinical Trials Assistance Corporation
Las Vegas, Nevada
We have audited the Balance Sheet of Clinical Trials Assistance Corporation
(the "Company"), as of December 31, 2003, and the related Statement of
Operations, Stockholders' Equity, and Cash Flows for the year ended December
31, 2003 and for the period ended December 31, 2002. These financial
statements are the responsibility of the Company's management. Our
responsibility is to express an opinion on these financial statements based on
our audit.
We conducted our audit in accordance with generally accepted auditing standards
in the United States of America. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on
a test basis, evidence supporting the amounts and disclosures in the financial
statement presentation. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We believe that our
audit provides a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Clinical Trials Assistance
Corporation as of December 31, 2003, and the results of its operations and cash
flows for the year ended December 31, 2003 and for the period ended December
31, 2002, in conformity with generally accepted accounting principles in the
United States of America.
Beckstead and Watts, LLP
January 16, 2004
F-1
Clinical Trials Assistance Corporation
Balance Sheet
Balance Sheet
December 31,
2003
------------
Assets
Current assets:
Cash $ 62,619
------------
62,619
------------
$ 62,619
============
Liabilities and Stockholders' Equity
Current liabilities $ -
Stockholders' equity:
Preferred stock - Series A, $0.001 par value, 2,000,000
shares authorized, no shares issued and outstanding -
Preferred stock - Series B, $0.001 par value, 2,000,000
shares authorized, no shares issued and outstanding -
Preferred stock - Series C, $0.001 par value, 1,000,000
shares authorized, no shares issued and outstanding -
Common stock - Class A, $0.001 par value, 20,000,000 shares
authorized, 12,000,000 shares issued and outstanding 12,000
Additional paid-in capital 47,000
Retained earnings 3,619
------------
62,619
------------
$ 62,619
============
The accompanying notes are an integral part of these financial statements.
F-2
Clinical Trials Assistance Corporation
Statement of Operations
Statement of Operations
For the year April 22, 2002
Ended (Inception) to
December 31, December 31,
2003 2002
------------ ------------
Revenue $ 195,576 $ 7,200
Cost of services 45,476 -
------------ ------------
150,100 7,200
Expenses:
Executive compensation - 8,000
General & administrative expenses 103,390 26,291
General & administrative expenses -
related party 14,400 1,600
------------ ------------
117,790 35,891
------------ ------------
Net income (loss) $ 32,310 $ (28,691)
============ ============
Weighted average number of common shares
outstanding - basic and fully diluted 12,000,000 12,000,000
============ ============
Net income (loss) per share - basic and fully
diluted $ 0.00 $ (0.00)
============ ============
The accompanying notes are an integral part of these financial statements.
F-3
Clinical Trials Assistance Corporation
Statement of Changes in Stockholders' Equity
Statement of Changes in Stockholders' Equity
(Deficit)
Accumulated
Common Stock Additional During Total
------------------ Paid-in Development Stockholders'
Shares Amount Capital Stage Equity
---------- ------- ---------- --------- -------------
April 2002
Founder shares
issued for cash 10,000,000 $10,000 $ 5,000 $ 15,000
September 2002
504 offering
issued for cash 2,000,000 2,000 18,000 20,000
December 2002
Donated capital 9,600 9,600
Net (loss)
April 22, 2002
(inception) to
December 31, 2002 (28,691) (28,691)
---------- ------- ---------- --------- -------------
Balance,
December 31, 2002 12,000,000 $12,000 $ 32,600 $(28,691) $ 15,909
---------- ------- ---------- --------- -------------
December 2003
Donated capital 14,400 14,400
Net income
for the year ended
December 31, 2003 32,310 32,310
---------- ------- ---------- --------- -------------
Balance,
December 31, 2003 12,000,000 $12,000 $ 47,000 $ 3,619 $ 62,619
========== ======= ========== ========= =============
The accompanying notes are an integral part of these financial statements.
F-4
Clinical Trials Assistance Corporation
Statement of Cash Flows
Statement of Cash Flows
For the year April 22, 2002
Ended (Inception) to
December 31, December 31,
2003 2002
------------ ------------
Cash flows from operating activities
Net income (loss) $ 32,310 $ (28,691)
Donated capital 14,400
Non-cash general and administrative expenses - 1,600
Non-cash executive compensation - 8,000
Adjustments to reconcile net (loss) to net cash
(used) by operating activities:
Increase in accounts payable - -
------------ ------------
Net cash provided (used) by operating activities 46,710 (19,091)
------------ ------------
Cash flows from investing activities - -
------------ ------------
Cash flows from financing activities
Issuances of common stock - 35,000
------------ ------------
Net cash provided by financing activities - 35,000
------------ ------------
Net increase in cash 46,710 15,909
Cash - beginning 15,909 -
------------ ------------
Cash - ending $ 62,619 $ 15,909
============ ============
Supplemental disclosures:
Interest paid $ - $ -
============ ============
Income taxes paid $ - $ -
============ ============
The accompanying notes are an integral part of these financial statements.
F-5
CLINICAL TRIALS ASSISTANCE CORPORATION
FOOTNOTES
NOTE 1 - HISTORY AND ORGANIZATION OF THE COMPANY
The Company was organized April 22, 2002 (Date of Inception) under the laws of
the State of Nevada, as Clinical Trials Assistance Corporation. The Company
helps physician researchers recruit appropriate patients to participate in
specific clinical research trials sponsored by the pharmaceutical industry.
NOTE 2 - ACCOUNTING POLICIES AND PROCEDURES
Cash and cash equivalents
-------------------------
The Company maintains a cash balance in a non-interest-bearing account that
currently does not exceed federally insured limits. For the purpose of the
statements of cash flows, all highly liquid investments with an original
maturity of three months or less are considered to be cash equivalents. There
are no cash equivalents as of December 31, 2003.
Revenue recognition
-------------------
The Company recognizes revenue as it invoices its customers (physician
researchers) on a "completed contract basis" based on the number of patients
it generates to call the research center for an appointment to participate in
a clinical study. Costs are recognized upon completion of the contracted
recruitment campaign in order to match revenue generated from the campaign.
For the year ended December 31, 2003, the Company recognized a total of
$195,576 in revenue.
Advertising costs
-----------------
The Company expenses all costs of advertising as incurred. There were no
advertising costs included in general and administrative expenses as of
December 31, 2003.
Use of estimates
----------------
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenue and expenses during the reporting period.
Actual results could differ from those estimates.
F-6
CLINICAL TRIALS ASSISTANCE CORPORATION
(A DEVELOPMENT STAGE COMPANY)
FOOTNOTES
Fair value of financial instruments
-----------------------------------
Fair value estimates discussed herein are based upon certain market
assumptions and pertinent information available to management as of December
31, 2003. The respective carrying value of certain on-balance-sheet financial
instruments approximated their fair values. These financial instruments
include cash and accounts payable. Fair values were assumed to approximate
carrying values for cash and payables because they are short term in nature
and their carrying amounts approximate fair values or they are payable on
demand.
Impairment of long-lived assets
-------------------------------
Long-lived assets held and used by the Company are reviewed for possible
impairment whenever events or circumstances indicate the carrying amount of an
asset may not be recoverable or is impaired. No such impairments have been
identified by management at December 31, 2003.
Reporting on the costs of start-up activities
---------------------------------------------
Statement of Position 98-5 (SOP 98-5), "Reporting on the Costs of Start-Up
Activities," which provides guidance on the financial reporting of start-up
costs and organizational costs, requires most costs of start-up activities and
organizational costs to be expensed as incurred. SOP 98-5 is effective for
fiscal years beginning after December 15, 1998. With the adoption of SOP 98-
5, there has been little or no effect on the Company's financial statements.
Loss per share
--------------
Net loss per share is provided in accordance with Statement of Financial
Accounting Standards No. 128 (SFAS #128) "Earnings Per Share". Basic loss per
share is computed by dividing losses available to common stockholders by the
weighted average number of common shares outstanding during the period. As of
December 31, 2003, the Company had no dilutive common stock equivalents, such
as stock options or warrants.
Dividends
---------
The Company has not yet adopted any policy regarding payment of dividends. No
dividends have been paid or declared since inception.
F-7
CLINICAL TRIALS ASSISTANCE CORPORATION
(A DEVELOPMENT STAGE COMPANY)
FOOTNOTES
Segment reporting
-----------------
The Company follows Statement of Financial Accounting Standards No. 130,
"Disclosures about Segments of an Enterprise and Related Information." The
Company operates as a single segment and will evaluate additional segment
disclosure requirements as it expands its operations.
Income taxes
------------
The Company follows Statement of Financial Accounting Standard No. 109,
"Accounting for Income Taxes" ("SFAS No. 109") for recording the provision for
income taxes. Deferred tax assets and liabilities are computed based upon the
difference between the financial statement and income tax basis of assets and
liabilities using the enacted marginal tax rate applicable when the related
asset or liability is expected to be realized or settled. Deferred income tax
expenses or benefits are based on the changes in the asset or liability each
period. If available evidence suggests that it is more likely than not that
some portion or all of the deferred tax assets will not be realized, a
valuation allowance is required to reduce the deferred tax assets to the
amount that is more likely than not to be realized. Future changes in such
valuation allowance are included in the provision for deferred income taxes in
the period of change.
Deferred income taxes may arise from temporary differences resulting from
income and expense items reported for financial accounting and tax purposes in
different periods. Deferred taxes are classified as current or non-current,
depending on the classification of assets and liabilities to which they
relate. Deferred taxes arising from temporary differences that are not
related to an asset or liability are classified as current or non-current
depending on the periods in which the temporary differences are expected to
reverse.
Recent pronouncements
---------------------
In July 2002, the FASB issued SFAS No. 146, "Accounting for Costs Associated
with Exit or Disposal Activities", which addresses financial accounting and
reporting for costs associated with exit or disposal activities and
supersedes EITF No. 94-3, "Liability Recognition for Certain Employee
Termination Benefits and Other Costs to Exit an Activity (including Certain
Costs Incurred in a Restructuring)." SFAS No. 146 requires that a liability
for a cost associated with an exit or disposal activity be recognized when
the liability is incurred. Under EITF No. 94-3, a liability for an exit cost
was recognized at the date of an entity's commitment to an exit plan. SFAS
No. 146 also establishes that the liability should initially be measured and
recorded at fair value. The provisions of SFAS No. 146 will be adopted for
exit or disposal activities that are initiated after December 31, 2002.
F-8
CLINICAL TRIALS ASSISTANCE CORPORATION
(A DEVELOPMENT STAGE COMPANY)
FOOTNOTES
Recent pronouncements (Continued)
---------------------------------
In December 2002, the FASB issued SFAS No. 148, "Accounting for Stock-Based
Compensation-Transition and Disclosure-an amendment of SFAS No. 123." This
Statement amends SFAS No. 123, "Accounting for Stock-Based Compensation", to
provide alternative methods of transition for a voluntary change to the fair
value based method of accounting for stock-based employee compensation. In
addition, this statement amends the disclosure requirements of SFAS No. 123
to require prominent disclosures in both annual and interim financial
statements about the method of accounting for stock-based employee
compensation and the effect of the method used on reported results. The
adoption of SFAS No. 148 is not expected to have a material impact on the
company's financial position or results of operations.
In November 2002, the FASB issued FASB Interpretation ("FIN") No. 45,
"Guarantors Accounting and Disclosure Requirements for Guarantees, Including
Indirect Guarantees and Indebtedness of Others", an interpretation of FIN No.
5, 57 and 107, and rescission of FIN No. 34, "Disclosure of Indirect
Guarantees of Indebtedness of Others". FIN 45 elaborates on the disclosures
to be made by the guarantor in its interim and annual financial statements
about its obligations under certain guarantees that it has issued. It also
requires that a guarantor recognize, at the inception of a guarantee, a
liability for the fair value of the obligation undertaken in issuing the
guarantee. The initial recognition and measurement provisions of this
interpretation are applicable on a prospective basis to guarantees issued or
modified after December 31, 2002; while, the provisions of the disclosure
requirements are effective for financial statements of interim or annual
periods ending after December 15, 2002. The company believes that the
adoption of such interpretation will not have a material impact on its
financial position or results of operations and will adopt such
interpretation during fiscal year 2003, as required.
In January 2003, the FASB issued FIN No. 46, "Consolidation of Variable
Interest Entities", an interpretation of Accounting Research Bulletin No. 51.
FIN No. 46 requires that variable interest entities be consolidated by a
company if that company is subject to a majority of the risk of loss from the
variable interest entity's activities or is entitled to receive a majority of
the entity's residual returns or both. FIN No. 46 also requires disclosures
about variable interest entities that companies are not required to
consolidate but in which a company has a significant variable interest. The
consolidation requirements of FIN No. 46 will apply immediately to variable
interest entities created after January 31, 2003. The consolidation
requirements will apply to entities established prior to January 31, 2003 in
the first fiscal year or interim period beginning after June 15, 2003. The
disclosure requirements will apply in all financial statements issued after
January 31, 2003. The company will begin to adopt the provisions of FIN No.
46 during the first quarter of fiscal 2003.
F-9
CLINICAL TRIALS ASSISTANCE CORPORATION
(A DEVELOPMENT STAGE COMPANY)
FOOTNOTES
Stock-Based Compensation
------------------------
The Company accounts for stock-based awards to employees in accordance with
Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to
Employees" and related interpretations and has adopted the disclosure-only
alternative of SFAS No. 123, "Accounting for Stock-Based Compensation."
Options granted to consultants, independent representatives and other non-
employees are accounted for using the fair value method as prescribed by SFAS
No. 123.
Year end
--------
The Company has adopted December 31 as its fiscal year end.
NOTE 3 - INCOME TAXES
The Company accounts for income taxes under Statement of Financial Accounting
Standards No. 109, "Accounting for Income Taxes" ("SFAS No. 109"), which
requires use of the liability method. SFAS No. 109 provides that deferred
tax assets and liabilities are recorded based on the differences between the
tax bases of assets and liabilities and their carrying amounts for financial
reporting purposes, referred to as temporary differences. Deferred tax assets
and liabilities at the end of each period are determined using the currently
enacted tax rates applied to taxable income in the periods in which the
deferred tax assets and liabilities are expected to be settled or realized.
The provision for income taxes differs from the amount computed by applying the
statutory federal income tax rate to income before provision for income taxes.
The sources and tax effects of the differences are as follows:
U.S federal statutory rate (34.0%)
Valuation reserve 34.0%
-------
Total -%
F-10
CLINICAL TRIALS ASSISTANCE CORPORATION
(A DEVELOPMENT STAGE COMPANY)
FOOTNOTES
NOTE 4 - STOCKHOLDER'S EQUITY
The Company is authorized to issue 20,000,000 shares of $0.001 par value class
A common stock, 2,000,000 shares of $0.001 par value series A preferred stock,
2,000,000 shares of $0.001 par value series B preferred stock, and 1,000,000
shares of $0.001 par value series C preferred stock. The series A preferred
stock has voting rights with each share having a voting weight equal to 10
shares of 0.001 par value class A common stock, and each share may be converted
to 10 shares of 0.001 par value class A common stock. The series B preferred
stock has voting rights with each share having a voting weight equal to 2
shares of 0.001 par value class A common stock, and each share may be converted
to 2 shares of 0.001 par value class A common stock. The series C preferred
stock has no voting rights.
On April 30, 2002, the Company issued 10,000,000 shares of its $0.001 par value
class A common stock to an individual who is an officer and director of the
Company in exchange for cash of $15,000.
On December 31, 2002, the Company closed and issued 2,000,000 shares of its
$0.001 par value class A common stock in a Regulation D, Rule 504 offering for
total cash received of $20,000.
There have been no other issuances of common and/or preferred stock.
NOTE 5 - WARRANTS AND OPTIONS
As of December 31, 2003, there are no warrants or options outstanding to
acquire any additional shares of common and/ or preferred stock.
NOTE 6 - RELATED PARTY TRANSACTIONS
On April 30, 2002, the Company issued 10,000,000 shares of its $0.001 par value
class A common stock to an individual who is an officer and director of the
Company in exchange for cash of $15,000.
F-11
CLINICAL TRIALS ASSISTANCE CORPORATION
(A DEVELOPMENT STAGE COMPANY)
FOOTNOTES
NOTE 6 - RELATED PARTY TRANSACTIONS (CONTINUED)
An officer of the Company agreed to take no salary until the Company can
generate enough revenues to support salaries on a regular basis. The estimated
fair market value of the services rendered is valued at $12,000 per year.
Total officer compensation expense is $12,000 for the year ended December 31,
2003. The offsetting accounting entry is included in "paid-in capital" since
the officer does not expect to be compensated until the Company can generate
enough revenues to support salaries on a regular basis.
As of December 31, 2003, the Company generated $14,400 in revenue from its
pilot program with one physician researcher, Eugene Boling, M.D., owner of
Boling Clinical Trials. Dr. Boling is also a Company director. The Company
presented Dr. Boling with an invoice for expenses it incurred in recruiting
patients through a mail program. Boling Clinical Trials paid the Company for
this invoice of $14,400.
F-12
ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE.
Not applicable.
ITEM 8A. CONTROLS AND PROCEDURES
As of December 31, 2003, Clinical Trials Assistance Corporation carried out an
evaluation of the effectiveness of the design and operation of its disclosure
controls and procedures. This evaluation was carried out under the supervision
and with the participation of management, including our Chief Principal
Officer/Chief Financial Officer. Based upon that evaluation, our Chief
Principal Officer/Chief Financial Officer concluded that Clinical Trials
Assistance Corporation disclosure controls and procedures are effective. There
have been no significant changes in our internal controls or in other factors
that could significantly affect internal controls subsequent to the date we
carried out the evaluation.
25
PART III
ITEM 9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS;
COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE ACT.
The names, ages and positions of the Company's directors and executive officers
are as follows:
Name Age Position Appointed
------------ --- --------------------------- ---------
Kamill Rohny 63 Chairman of the Board April, 2002
President, CEO, CFO
Secretary
Eugene P. Boling, M.D. 53 Director Nov., 2002
-----------------------------------------------------------------------------
B. Family relationships
None.
Work Experience
---------------
Kamill Rohny, Director, President, CEO/CFO, Secretary
-----------------------------------------------------------------
Kamill Rohny had 32-years of service (December, 1969 through February, 2002)
with Procter & Gamble Pharmaceuticals (formerly known as Norwich Eaton
Pharmaceuticals). He voluntarily retired from the Company in February,
2002.
While at Procter and Gamble Pharmaceuticals, Kamill Rohny was a Regional
Scientific Manager of the Professional Scientific Organization of Procter &
Gamble Pharmaceuticals, leading and executing educational and clinical
research projects, disseminating scientific data to national and regional
physician thought leaders, in one-on-one and group settings. This resulted
in the education of current and future treatment modalities.
26
Key strategies and activities included but were not limited to, working with
clinical research departments in identifying investigators, clinical research
centers, including site assessment and pre-study visits and served as a
conduit for handling independent research proposals.
During his last year at Procter and Gamble Pharmaceuticals, Mr. Rohny designed,
tested and implemented a patient recruitment program for people with
osteoporosis that helped participants improve their bone health through self
management. The company implemented his recruitment programs on a national
level. These programs were not offered to physicians by any other
pharmaceutical company. Pharmaceutical companies are in business to sell their
pharmaceutical products through physician prescriptions. This was a patient
recruitment program offered by a pharmaceutical which helped build goodwill,
patient compliance and did not directly sell pharmaceutical products. After Mr.
Rohny retired from Procter and Gamble Pharmaceuticals, his former employer did
not actively pursue patient recruitment programs.
He plans to develop 25-30 hours per week to Clinical Trials Assistance
Corporation ("CTAL").
Eugene P. Boling, M.D., F.A.C.P., F.A.C.R., Director
----------------------------------------------------
Office Address: 8283 Grove Avenue, Suite 203, Rancho Cucamonga, California
91730; Medical License # G57099
Private Practice Physician: Establishment of a single specialty group
Rheumatology practice. The practice services an area in Southern California
populated by of 500-600,000 people. Practice employs and is supported by
twelve full time and five part-time personnel (not including the physician),
1986 to present.
Research Practice: Boling Clinical Trials a.k.a. Inland Clinical Research.
1989 to present. Boling Clinical Trials works with approximately fifteen
pharmaceutical and biotechnology companies, in conducting human clinical
trials for pharmaceutical products in their final stages of approval by the
FDA. Dr. Boling is responsible for screening clinical study candidates and
evaluating their response to these treatment modalities. The results of
his work will help determine whether or not a pharmaceutical product offers
any marked patient benefit and its subsequent FDA approval.
Clinical Assistant Professor, Rheumatology Department University of Southern
California/ Los Angeles County Hospital 1987-1994 Clinical Assistant
Professor, Rheumatology Department, Department of Medicine, Loma Linda
University Loma Linda, California 1987-1997.
Military Service: Staff Internist, Malcolm Grow USAF Hospital, Andrew AFB,
Wash. D.C. 1979-1981; Fellowship 1981-1983; Staff Rheumatologist, Malcolm Grow,
USAF Hospital, 1983-1986; Visiting Research Institute, Naval Medical Research
Institute, Bethesda, Maryland, 1983-1986; Acting Director, Malcolm Grow U.S.
Air Force Rheumatology fellowship program, 1983-1986.
27
Education: FELLOWSHIP: Johns Hopkins University, 1981-1983. Baltimore,
Maryland Rheumatology fellowship; RESIDENCY: University of Utah, 1977-1979.
Salt Lake City, Utah. INTERNSHIP: University of Utah, 1976-1977. Bachelor
of Science, University of California at Los Angeles School of Medicine,
1972-1976; M.D. Degree. Loyola University Los Angeles, 1968-1972.
SECTION 16(A) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE
Section 16(a) of the Securities Exchange Act of 1934 requires our directors and
executive officers, and persons who beneficially own more than ten percent of a
registered class of our equity securities (referred to as "reporting persons"),
to file with the Securities and Exchange Commission initial reports of
ownership and reports of changes in ownership of common stock and other Clinical
Trials Assistance Corporation equity securities. Reporting persons are required
by Commission regulations to furnish us with copies of all Section 16(a) forms
they file.
ITEM 10. EXECUTIVE COMPENSATION.
As a result of our the Company's current limited available cash, no officer
or director received compensation during the fiscal year ended December 31,
2003. Clinical Trials Assistance Corporation intends to pay salaries when
cash flow permits. No officer or director received stock options or other
non-cash compensation during the fiscal year ended December 31, 2003.
SUMMARY COMPENSATION TABLES
------------------------------------------------------
Annual Compensation
------------------------------------------------------
Name and Other Annual
Principal Position Year Salary ($) Bonus ($) Compensation ($)
-------------------------------------------------------------------------------
Kamill Rohny
Director,
CEO/CFO,
President 2003 -0- -0- -0-
2002 -0- -0- -0-
-------------------------------------------------------------------------------
Eugene Boling, M.D.
Director 2003 -0- -0- -0-
2002 -0- -0- -0-
-------------------------------------------------------------------------------
28
Long Term Compensation Table
--------------------------------------------------------
Long Term Compensation
--------------------------------------------------------
Awards Payouts
--------------------------------------------------------
Restricted Stock Securities LTIP All Other
Name and Principal Award(s)($) Underlying Options/ Payouts Compensation
Position Year SARs(#) ($) ($)
-------------------------------------------------------------------------------
Kamill Rohny
Director
CEO/CFO,
President 2003 -0- -0- -0- -0-
2002 -0- -0- -0- -0-
-------------------------------------------------------------------------------
Eugene Boling, M.D.
Director 2003 -0- -0- -0- -0-
2002 -0- -0- -0- -0-
-------------------------------------------------------------------------------
The Company currently does not have employment agreements with its
executive officer. The executive officer will not draw any salary from
the Company, and the Company - in order to prudently manage its limited
financial resources - does not plan on compensating its executive officers
for their present services rendered to the Company for the foreseeable
future while Clinical Trials is in its early stages.
ITEM 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
A. Security Ownership
The table below sets forth certain information with respect to
beneficial ownership of our stock as of March 16, 2003 by:
o persons known by us to be the beneficial owners of more
than five percent (5%) of our issued and outstanding
common or preferred stock;
o each of our executive officers and directors; and
o all of our officers and directors as a group.
29
Amount
Title Name and Address of shares Percent
of of Beneficial held by Date of
Class Owner of Shares Position Owner (1) Acquired Class (2)
--------------------------------------------------------------------------------
Common Kamill Rohny (3) Pres./CEO 30,000,000 04/30/02 83.33%
Eugene P. Boling, M.D.(3) Director 0 - -
--------------------------------------------------------------------------------
All Executive Officers as
a Group (2 persons) 30,000,000 83.33%
(1) This ownership number reflect the March 15, 2004 three-for-one forward
stock split.
(2) The percentages listed in the Percent of Class column are based upon
36,000,000 issued and outstanding shares of Common Stock.
(3) c/o Clinical Trials Assistance Corporation, 2078 Redwood Crest, Vista,
California 92081.
B. Persons Sharing Ownership of Control of Shares
The following own or share the power to vote five percent (5%) or more of the
Company's securities: Kamill Rohny, President, Clinical Trials Assistance
Corporation has indicated that he would vote in favor of the Proposals in this
Proxy Statement.
C. Non-voting Securities and Principal Holders Thereof
The Company has not issued any non-voting securities.
D. Options, Warrants and Rights
There are outstanding options, warrants or rights to purchase securities
of the Company. At the Company's annual shareholder's meeting held on March 5,
2004, the sharesholders approved the issuance warrants to purchase up to
1,800,000 shares of the Company's Common Stock. No warrants have been issued.
E. Parents of the Issuer
Under the definition of parent, as including any person or business
entity who controls substantially all (more than 80%) of the issuers of
common stock, the Company has no parents.
30
ITEM 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
By Board Resolution, the Company hired the professional services of Beckstead
and Watts, LLP, Certified Public Accountants, to perform audited financials for
the Company. The members of the firm of Beckstead and Watts, LLP own no stock
in the Company.
The Company conducts evaluations of its recruiting methods at Boling
Clinical Trials, a.k.a. Inland Clinical Research in Rancho Cucamonga,
California. This research facility is owned and operated by Eugene P. Boling,
M.D. who is a Director of the Company. This arrangement benefits both the
Company and Dr. Boling, in that, it helps the Company develop and define its
methodologies for recruiting patients in a real clinical setting; and, it helps
Dr. Boling recruit patients for his clinical studies. Dr. Boling receives
no direct compensation from the Company other than the Company helping him to
recruit patients. Dr. Boling provides the management of the Company with
feedback as to which methodologies work best in recruiting patients during
this developmental program. Dr. Boling has paid Clinical Trials Assistance
Corporation $14,400 to cover hard costs which included postage for a
recruitment mailing.
Since Dr. Boling performs services for the Company at no cost, and helps the
Company improve its recruitment methodologies, the fees Boling Clinical Trials
paid to the Company were on terms more favorable as could have been obtained
from unrelated third parties. This is due to the fact that services provided
by Boling Clinical Trials are more valuable then the services the Company
provides to Boling Clinical Trials. Said differently, Boling Clinical Trials
does not need CTAL to build its business; however, CTAL needs Boling Clinical
Trials to build its business and help validate its patient recruitment
methodologies. Without Boling Clinical Trials, it would be very difficult for
the Company's management to field test recruitment methods for different
patient types, e.g., osteoarthritis ("OA")patient recruitment, rheumatoid
arthritis ("RA") patient recruitment.
The officers and directors of the Company are involved in other business
activities and may, in the future, become involved in other business
opportunities. If a specific business opportunity becomes available, such
persons may face a conflict in selecting between the Company and their other
business interests. The Company has not formulated a policy for the
resolution of such conflicts.
31
ITEM 13. EXHIBITS AND REPORTS ON FORM 8-K.
(a) EXHIBITS.
3.3 Amended Articles of Incorporation, filed with the Nevada
Secretary of State on March 8, 2004.
31.1 Certification of Principal Executive Officer and Chief
Financial Officer to Section 302 of the Sarbanes-Oxley Act
of 2002, promulgated under the Securities Exchange Act of
1934, as amended.
32.1 Certification of Chief Executive Officer and Chief Financial
Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
(b) REPORTS ON FORM 8-K
The Company filed a Current Report dated March 11, 2003 on Form 8-K
containing information pursuant to Item 4 ("Changes in Accountants")
entitled "Changes in Registrant's Certifying Account." (See Item 8 above,
entitled, "Changes in and Disagreements with Accountants on Accounting")
32
Item 14. Principal Accountant Fees and Services
AUDIT FEES
The aggregate fees billed to the Company by Beckstead and Watts, LLP for the
audit of its annual financial statements for the fiscal year ended December 31,
2002, as filed on Form 10-KSB and for the reviews of the financial statements
included in the Company's quarterly reports on Form 10-QSB during 2003, and for
audit of the period April 22, 2002 (Inception) through December 31, 2003 as
filed in the Company's Registration Statement on Form 10SB12G were $12,000.
AUDIT-RELATED FEES
Beckstead and Watts, LLP did not bill the Company for any assurance and related
services reasonably related to the performance of the audit or review of the
Company's financial statements which are not disclosed above.
TAX FEES
Beckstead and Watts, LLP did not bill the Company for professional services
rendered for tax compliance, tax advice, and tax planning in fiscal 2003.
ALL OTHER FEES
There were no other fees billed to the Company by Beckstead and Watts, LLP
since its inception on April 22, 2002 through December 31, 2003.
33
SIGNATURES
In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934,
as amended, the registrant caused this report to be signed on its behalf by the
undersigned and duly authorized on March 22, 2004.
Clinical Trials Assistance Corporation
--------------------------------------
(Registrant)
By: /s/ Kamill Rohny
---------------------------
Kamill Rohny
Chairman of the Board
President
Chief Executive Officer
Chief Financial Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has caused this report to be signed on its behalf by the
undersigned, hereunto duly authorized.
Date: March 22, 2004 By: /s/ Kamill Rohny
--------------------------------
Kamill Rohny
President, CEO and CFO
Director and Corporate Secretary
34