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FORM 10-K/A
(AMENDMENT NO. 1)
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 1995
Commission file number 340-23520
QUINTILES TRANSNATIONAL CORP.
(Exact name of registrant as specified in its charter)
North Carolina 56-1714315
(State of incorporation) (I.R.S. Employer Identification Number)
4709 Creekstone Drive, Suite 300
Durham, North Carolina 27703-8411
(Address of principal executive office) (Zip Code)
Registrant's telephone number, including area code: (919) 941-2000
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.01 par value per share
(Title of Class)
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 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
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Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K is not contained herein, and will not 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-K or any
amendment of this Form 10-K. [x]
The aggregate market value of the registrant's Common Stock at February
26, 1996 held by those persons deemed by the registrant to be non-affiliates
was approximately $979,565,952.
As of February 26, 1996, there were 21,713,736 shares of the registrant's
Common Stock, $.01 par value per share, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
<TABLE>
<CAPTION>
Document Where Incorporated
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<S> <C> <C>
1. Annual Report to Shareholders for the year ended December 31, 1995 Part II
2. Proxy Statement for the Annual Meeting of Shareholders to be held April 24, 1996 Part III
</TABLE>
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ITEM 1. BUSINESS
GENERAL
The Company is a leading CRO providing a broad range of integrated product
development services on a global basis for the pharmaceutical and biotechnology
industries. The Company's professional services include clinical trials
management, data management, biostatistical analysis, centralized clinical
laboratory services, pre-clinical and Phase I testing, study design,
formulation and packaging of clinical trial drugs, and strategic, regulatory
and health economics consulting.
The Company, founded in 1982, has grown primarily through internal
expansion supplemented by strategic acquisitions.
In March 1995, Quintiles Scotland Limited ("Quintiles Scotland"), a
wholly-owned subsidiary of the Company, acquired assets of a drug development
facility in Edinburgh, Scotland, from Syntex Pharmaceuticals Limited
("Syntex"), a member of the Roche group based in Basel, Switzerland. The
assets acquired consist primarily of a modern 300,000 square foot building and
related equipment previously used by Syntex as an internal service center to
support its drug development activities. Quintiles Scotland made a purchase
commitment valued at approximately $20 million with payment due in December
1999. Quintiles Scotland agreed to employ up to 200 existing Syntex employees
through 1999. Syntex agreed to pay Quintiles Scotland approximately $5 million
as a facility commitment fee and to cover certain transition costs, as well as
approximately $13 million per year for three years in return for services to be
provided by Quintiles Scotland. Also, Quintiles Scotland entered into a
long-term ground lease obligation at market rates. This transaction and the
related agreements complement the Company's growth strategy for providing
comprehensive worldwide drug development services. Specifically, this facility
will allow the Company to formulate and package clinical trial drugs for
blinded studies, expand clinical research and data management services in
Europe, provide additional pre-clinical drug development facilities and build a
European clinical diagnostic laboratory over the long term.
In May 1995, a newly-formed, wholly-owned subsidiary of the Company
acquired San Diego Clinical Research Associates ("SDCRA"), a clinical research
company specializing in infectious and respiratory diseases in a transaction
valued at approximately $2.4 million. The Company acquired SDCRA through a
share exchange. SDCRA, located in Carlsbad, California, maintains a database
of independent clinical research associates who monitor clinical trials in all
therapeutic areas on a contract basis throughout the United States. This
acquisition enhanced the Company's ability to provide comprehensive services to
clients worldwide.
In May 1995, a wholly-owned French subsidiary of the Company acquired
Benefit International S.A. ("Benefit"), a research organization specializing in
pharmacoeconomic and quality-of-life evaluations, for approximately 565,994
shares of the Company's Common Stock and approximately $4.3 million in cash.
Benefit employed 75 professionals which provided the Company with international
experience in pharmacoeconomics and health care management that will complement
the Company's existing global resources in clinical research and development.
In September 1995, the Company acquired all of the stock of G.D.R.U.
Limited ("GDRU"), a Phase I clinical trials facility in London, for a purchase
price of approximately $9.5 million in cash. This acquisition enhanced the
Company's ability to provide a full range of Phase I services.
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In October 1995, the Company closed its second public offering and sold
1,009,980 shares of its Common Stock at $59 per share to a group of
underwriters led by Morgan Stanley & Co. Incorporated and Goldman Sachs & Co.
Incorporated.
Also in October 1995, the Company's Board of Directors authorized a
two-for-one split of the Company's Common Stock, which was effected in November
in the form of a 100% stock dividend.
In February 1996, the Company acquired all of the stock of PMC Contract
Research AB ("PMC"), a contract research organization located in Uppsala,
Sweden, for approximately 273,000 shares of the Company's Common Stock.
Additionally, approximately $1.3 million in cash was paid to a dissenting PMC
shareholder. This acquisition will expand the Company's ability to provide
drug development services in Scandinavia and position the Company for further
growth in that region.
The Company added 16 offices in 1995 and has added two offices so far in
1996. The Company intends for these offices to expand the Company's geographic
presence and accommodate past and future growth. The new offices are in Milan,
Italy; Weil am Rhein, Germany; Osaka, Japan; Bethesda, Maryland; Edinburgh,
Scotland; Gennevilliers, France; Leiden, The Netherlands; Montreal, Canada;
Singapore; Copenhagen, Denmark; Buenos Aires, Argentina; London, England;
Strasbourg, France; and Uppsala, Sweden. The remaining four offices added
through the Company's 1995 acquisitions were combined into the Company's
existing offices.
CRO INDUSTRY OVERVIEW
The CRO industry provides independent product development services for the
pharmaceutical and biotechnology industries, offering pre-clinical and clinical
services as well as post-marketing research. Generally, CROs derive
substantially all of their revenue from the research and development
expenditures of pharmaceutical and biotechnology companies. CROs manage
clinical trials, provide scientific evaluations and analyze the results
according to good clinical and laboratory practices as required by the
applicable regulatory authorities. The CRO industry consists of several
hundred small, limited-service providers, several medium-sized CROs and a few
full-service CROs with global operations.
TRENDS AFFECTING THE CRO INDUSTRY
In recent years, the global pharmaceutical and biotechnology industries
have outsourced significant drug development services to the CRO industry. The
Company believes that a number of factors will cause outsourcing to continue
and increase, including the following: (i) drug companies have responded to
margin pressures by focusing on more efficient ways of conducting business,
including using specialized therapeutic, data management and regulatory
expertise which certain CROs have to offer and shifting internal fixed costs to
variable costs by outsourcing, including on a preferred provider basis, and
including increasingly large and complex Phase III and IV studies generally
undertaken only by larger CROs; (ii) drug companies seek to maximize
profitability by pursuing concurrent regulatory approvals worldwide by
outsourcing to global CROs; (iii) many pharmaceutical companies are seeking to
obtain cost reduction synergies through consolidation with other firms, often
including increased outsourcing to CROs; (iv) increasingly stringent regulatory
requirements worldwide, together with recent efforts to develop global
harmonized regulatory standards, escalate the demands on data collection and
analysis and prompt outsourcing to CROs with global data management expertise;
(v) pharmaceutical companies are under increasing pressure to develop a
pipeline of new products, many of which (especially those for chronic
disorders) require complex clinical trials; and (vi) biotechnology companies
will continue to depend on outside sources for drug development as an
alternative to building infrastructure.
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The Company follows a focused strategy to capitalize on these favorable
market trends. The foundation of this strategy rests on four basic principles:
(i) extending the Company's leadership position in information technology to
provide state-of-the-art drug development services on a worldwide basis; (ii)
expanding the Company's geographic presence to support the worldwide needs of
the pharmaceutical and biotechnology industries; (iii) offering a full range of
drug development services to support the outsourcing needs of the
pharmaceutical and biotechnology industries; and (iv) offering specialized
services in all major therapeutic areas in order to facilitate an expedited
drug development process.
SERVICES
The Company provides a full range of pre-clinical and clinical research
and development services to the pharmaceutical and biotechnology industries.
The Company provides clinical trials management, data management,
biostatistical analysis, centralized clinical trial laboratory services,
pre-clinical and Phase I testing, study design, formulation and packaging of
clinical trial drugs for blinded studies, strategic, regulatory and health
economics consulting services and regulatory affairs services including product
registrations with regulatory authorities for its clients. The major
categories of services offered by the Company are as follows:
Clinical Trials Services
The Company offers comprehensive clinical trials services, a critical
element in obtaining regulatory approval for drugs. The Company has
specialized business units and extensive experience in the therapeutic areas of
central nervous system and oncology. The Company also has significant clinical
trials experience in the therapeutic areas of cardiopulmonary diseases,
hematology, immunology, endocrinology, dermatology, gastroenterology,
reproduction and fertility, respiratory illness, rheumatology and infectious
diseases, including AIDS. The Company is experienced in monitoring large
trials involving several thousand patients at several hundred sites and in
multinational trials conducted simultaneously in the United States, Europe and
the Asia-Pacific region.
The Company can manage every aspect of clinical trials in Phases I through
IV, including protocol development, case report from ("CRF") design,
feasibility studies, investigator selection, recruitment and training, site
initiation and monitoring, patient enrollment, development of training videos
and manuals for investigators and training of sponsor staff, and uses
innovative technology to increase monitoring efficiency of each investigational
site. Most of the Company's projects involve Phase II, III or IV clinical
trials, which generally are significantly larger and more complex than Phase I
trials. Previously, the Company's involvement in Phase I clinical trials
primarily consisted of study design and data management, and the Company
generally subcontracted with third parties for the facilities to conduct Phase
I trials. The acquisitions of GDRU and PMC, however, provided the Company with
access to facilities for directly conducting Phase I trials.
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The Company provides its clients with one or more of the following core
clinical trials services:
Study Design. The Company assists in preparing the study protocol and
CRFs and in investigator recruiting. The protocol defines the study's
medical issues to be examined, the number of patients required to produce
statistically valid results, the period of time over which they must be
tracked, the frequency and dosage of drug administration, and the study
procedures. The study's success often depends on the protocol's ability
to predict correctly the requirements of the applicable regulatory
authorities. Once the study protocol has been finalized, CRFs for
recording the desired information must be developed.
Investigator Recruitment. During the clinical trials, the drug is
administered to patients by physicians, also referred to as investigators,
at hospitals, clinics or other locations, also referred to as sites. The
Company solicits investigators' participation in the study. The
investigators contract directly with the sponsor or the CRO. The
successful identification and recruitment of investigators with the
appropriate expertise and an adequate base of patients to call upon who
satisfy the requirements of the study protocol are important to the
success of the trial.
Study Monitoring. The Company provides study monitoring services which
include investigational site initiation, patient enrollment assistance,
and data collection through subsequent site visits. These visits also
serve to assure the quality of the data, which is gathered according to
Good Clinical Practice, as well as meeting the sponsor's and regulatory
agency's requirements as specified in the study protocol.
In addition to the Company's core clinical trials management services, the
Company provides its clients with the following specialized services:
Treatment INDs. A treatment IND ("TIND") is an application by a
pharmaceutical sponsor and the associated procedure that allows patients
with a serious or immediately life-threatening disease, such as AIDS or
Alzheimer's disease, for which no comparable or satisfactory therapy is
available, to receive treatment with an investigational new drug. This
treatment is provided during the clinical trial phase of development, but
outside the controlled clinical trial. For promising new drugs, the TIND
has the advantage of getting the treatment into an expanded patient base
early, as well as allowing earlier publicity about the potential success
of the drug. Since the drug is made available as early as Phase II to
patients outside of clinical trials, TINDs have the commercial potential
of getting the most successful drugs approved for marketing earlier than
controlled clinical trials. When monitoring a clinical trial for a TIND,
the Company provides intensive electronic data monitoring to enable
frequent evaluation of new or low incidence side effects as well as to
satisfy the extensive reporting requirements of the United States Food and
Drug Administration ("FDA").
Information and Adverse Events Reporting. Through its 24-hour Clinical
Information Center ("CIC"), the Company provides global medical
surveillance services for large scale Phase II and III studies, TINDs,
post-marketing surveillance, compassionate use and other expanded access
programs. These services include standard collection, coding, evaluation,
and customized reporting, as well as multi-lingual adverse event
collection from multiple countries via network-based computers. The
Company has developed a proprietary system, QCASE(TM), for electronic
capture, processing and tracking of serious adverse events. These serious
adverse events can be reported with medical documentation to the sponsor
within 24-hours of receipt to meet FDA reporting requirements. Other
worldwide regulatory agencies also receive adverse event reporting in a
timely manner. In the case of time-critical adverse events, the CIC and
the
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Company's global, computerized, adverse event capability enable
reporting efficiencies for trials conducted in multiple countries
concurrently.
Centralized Clinical Trial Laboratory. In addition to providing
comprehensive safety and efficacy testing for clinical trials, the
Company's centralized clinical trial laboratory provides site-specific
study materials, customized lab report design and specimen archival and
management on behalf of a study sponsor. The centralized laboratory
features a 48-hour turnaround time for laboratory results and is capable
of providing direct electronic integration of laboratory data into safety
and efficacy reports for New Drug Application ("NDA") submissions, as well
as customized transfer of laboratory data directly to the sponsor's
database in preparation for an electronic regulatory filing. The Company
has developed two proprietary software systems, QNET(TM) and QLIMS(TM),
which allow electronic monitoring and management of the laboratory testing
process.
Formulation, Manufacturing and Packaging Services. The Company also
offers services to formulate a pharmaceutical product in a form
appropriate to deliver to humans for clinical trials and subsequent
marketing. The Company's support services for clinical trials also
include the manufacture of clinical trial supplies and the appropriate
packaging of drugs for double blinded studies. The Company has the
ability to formulate and package drugs for studies in Europe, the United
States, and other markets.
Clinical Data Management and Biostatistical Services
The Company has extensive experience in the United States and Europe in
the creation of scientific databases for all phases of the drug development
process, including the creation of customized databases to meet client-specific
formats, integrated databases to support NDA submissions and databases in
strict accordance with FDA and European specifications. The Company's data
management professionals assist in the development of study protocols and CRFs
as well as training materials for investigators. As patients are examined and
tests are conducted in accordance with the study protocol, data are recorded on
CRFs and laboratory reports. Data are collected by specially trained monitors
who may employ any one of a variety of data collection techniques. The Company
has developed proprietary software to streamline drug development processes,
including QAMS(TM), a computerized clinical trial administrative management
system, QDATA(TM), a network-based data management system, QTONE(TM), a remote
telephone data entry system, QFAX(TM), an electronic facsimile system for rapid
review and management of clinical study data and QCANDA(TM), a system for
electronic submission and review of NDA data. The Company also has developed a
proprietary imaging technology process, QSTAR(TM), which eliminates time and
minimizes potential errors in data management by electronically routing and
tracking optically scanned case report forms. The Company filed and has
pending an application for a United States patent for QSTAR(TM).
Health Economics
The Company's health economics services enable regulators, health care
providers and third parties to assess the pricing and cost effectiveness of new
medical therapies. The Company provides empirical economic data and
demonstration of cost effectiveness in development programs. The Company's
economists document critical economic advantages of the new drug design and
execute an integrated research program to support both regulatory approval and
post-approval pricing, marketing and reimbursement strategy. The Company's
health economics professionals also gather cost-benefit, quality-of-life, and
other pharmacoeconomic data electronically via the Company's wide area network
computer system and draw upon the Company's country-specific regulatory
experience to combine clinical and
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economic studies in a single design. The Company significantly expanded
its health economics capabilities in May 1995 by acquiring Benefit.
Pre-Clinical Research
The Company provides a wide array of pre-clinical and toxicology services
designed to produce the data required to identify, quantify and evaluate the
risks to humans resulting from the manufacture or use of pharmaceutical and
biotechnology products. Clients use the pre-clinical test results and the
Company's interpretative analysis of such results in connection with the
continued development of products or compounds, and submit such results to
domestic and foreign governmental agencies as part of their efforts to obtain
marketing approval of such substances. The Company offers a wide range of
testing and consulting services, including developmental and reproductive
toxicology, genetic toxicology, neurotoxicology, carcinogenicity testing,
pharmacology, analytical chemistry, pathology, metabolism and pharmacokinetics.
Medical and Regulatory Affairs Services
The Company provides comprehensive medical and regulatory product
registration services for pharmaceutical and biotechnology clients in North
America, Europe and Australia. The Company's medical services include medical
oversight of studies, review and interpretation of adverse experiences, medical
writing of reports and study protocols and strategic planning of drug
development programs. Regulatory services include regulatory strategy design,
document preparation, consultation, and liaison with various regulatory
agencies, including the FDA and the European Committee for Proprietary
Medicinal Products. The Company's regulatory affairs professionals help to
define the steps necessary to obtain registration in the most expeditious
manner.
CLIENTS AND MARKETING
The Company provides its research and development services on a global
basis to the pharmaceutical and biotechnology industries. For the year ended
December 31, 1995, approximately 52% of the Company's net revenue was
attributed to North American operations, 44% to European operations and four
percent to Asia-Pacific operations. During 1995 by net revenue, the Company's
business was approximately 79% clinical services and 21% pre-clinical,
laboratory services and formulation and packaging. For the year ended December
31, 1995, approximately 83% of the Company's net revenue was derived from
pharmaceutical companies, 11% from biotechnology clients and six percent from
other clients.
In 1995, two clients, Hoffman-La Roche Ltd and Procter & Gamble
Pharmaceuticals, Inc., each accounted for approximately 15% of the Company's
consolidated net revenue. Concentrations of business in the CRO industry are
not uncommon and are increasing as large pharmaceutical companies are
outsourcing larger clinical trial projects to fewer full-service CROs. The
Company is likely to experience such concentration in future years.
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The Company's marketing activities are conducted by business development
personnel in each of the Company's United States locations as well as the
Company's locations in the United Kingdom, Belgium, Canada, France, Germany,
Ireland, Italy, Japan, the Netherlands, Argentina, Denmark, Australia, Spain,
Sweden and Singapore. Most of the Company's business development personnel
have technical or scientific backgrounds and many are physicians,
pharmacologists, statisticians and regulatory affairs professionals. The
Company coordinates its worldwide marketing efforts through a computerized
system that is integrated into most of the Company's locations.
COMPETITION
The CRO industry consists of several hundred small, limited-service
providers, several medium-sized CROs, and a few full-service global drug
development companies. The Company believes that it is the second-largest CRO.
The CRO industry is consolidating and, in recent years, several large,
full-service competitors have emerged. This trend of industry consolidation
may result in greater competition among the larger CROs for clients and
acquisition candidates. The Company's primary competitors include Corning Lab
Services, Inc., a subsidiary of Corning, Inc., Applied Bioscience
International, Inc., Parexel International Corporation and ClinTrials Research
Inc. Additionally, the Company competes against other CROs and the in-house
research and development departments of pharmaceutical companies, as well as
universities and teaching hospitals.
Competitive factors include previous experience, medical and scientific
expertise in specific therapeutic areas, the quality of contract research, the
ability to organize and manage large-scale trials on a global basis, the
ability to manage large and complex medical databases, the ability to provide
statistical and regulatory services, the ability to recruit investigators, the
ability to integrate information technology with systems to improve the
efficiency of contract research, an international presence with strategically
located facilities, financial viability, and price. The Company believes that
the abilities to adopt and adapt to changing technologies in information
management, to manage large-scale clinical trials at multiple sites and to seek
multiple concurrent foreign approvals will distinguish leading CROs from the
rest of the CRO industry. The Company believes that it competes favorably in
these areas.
CONTRACTUAL ARRANGEMENTS
Most of the Company's contracts are fixed price, with some variable
components, and range in duration from a few months to several years.
Generally, for multi-year contracts involving clinical trials, a portion of the
contract fee is paid at the time the trial is initiated with performance-based
installments payable over the contract duration. Most of the Company's
contracts are terminable upon 15-90 days' notice by the client. Although the
contracts typically permit payment of certain fees for winding down the study
and, in some cases, a termination fee, the loss of a large contract or the loss
of multiple contracts could adversely affect the Company's future revenue and
profitability. Contracts may be terminated for a variety of reasons, including
the failure of a product to satisfy safety requirements, unexpected or
undesired results of the product, the client's decision to forego a particular
study or insufficient patient enrollment or investigator recruitment.
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BACKLOG
The Company believes that backlog is not a consistent indicator of future
results because backlog can be affected by a number of factors, including the
variable size and duration of projects, many of which are performed over
several years. Additionally, projects may be terminated by the client or
delayed by regulatory authorities for many reasons, including unexpected test
results. Moreover, the scope of a project can change during the course of a
study.
The Company reports backlog based on anticipated net revenue from
uncompleted projects which have been authorized by the client, through a
written contract or otherwise. Net revenue is defined as professional fee
income less reimbursed costs, which are principally investigator fees and
travel. Once work begins on a project, net revenue is recognized over the
duration of the project. Using this method of reporting backlog, at December
31, 1995, backlog was approximately $239 million, as compared to approximately
$156 million at December 31, 1994.
POTENTIAL LIABILITY AND INSURANCE
The Company attempts to manage its liability risk through contractual
indemnification provisions with clients and investigators hired by the Company
on behalf of its clients and through insurance. The contractual
indemnifications generally do not protect the Company against certain of its
own actions such as negligence. The contractual arrangements are subject to
negotiation with clients and the terms and scope of such indemnification vary
from client to client and from trial to trial. Although most of the Company's
clients are large well-capitalized companies, the financial performance of
these indemnities is not secured. Therefore, the Company bears the risk that
the indemnifying party may not have the financial ability to fulfill its
indemnification obligations. The Company maintains professional liability
insurance which covers worldwide territories in which the Company currently
does business and includes drug safety issues as well as data processing errors
and omissions. The Company could be materially and adversely affected if it
were required to pay damages or incur defense costs in connection with a claim
that is beyond the scope of an indemnity provision or beyond the level of
insurance coverage or where the indemnifying party does not fulfill its
indemnification obligations.
The Company believes that its liability risk in clinical trials is further
reduced by the role of institutional review boards ("IRBs") and various
regulatory requirements which include the need to obtain each patient's
informed consent to participate in the study. The FDA requires each human
clinical trial to be reviewed and approved by an IRB at each study site. An
IRB is an independent committee which approves the initiation of clinical
trials and reviews biomedical research involving human subjects. After a
clinical trial begins, an IRB monitors the protocol and the measures designed
to protect the patients. In Europe, this function is addressed by ethics
committees.
GOVERNMENT REGULATION
The pre-clinical and clinical testing services performed by the Company
are subject to various regulatory requirements designed to ensure the quality
and integrity of the testing process. Standards for conducting pre-clinical
and laboratory testing are embodied in Good Laboratory Practice regulations
("GLP"). GLP has been adopted by the Department of Health in the United
Kingdom, the FDA in the United Sates and similar regulatory authorities in
other parts of the world. GLP stipulates requirements for facilities,
equipment and professional staff. The regulations require standardized
procedures for studies, for recording and reporting data and for retaining
appropriate records.
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The Company has established quality assurance controls at its pre-clinical
facilities which monitor ongoing compliance with GLP regulations by auditing
test data and conducting regular inspections of testing procedures. The
relevant functions at the Company's pre-clinical facilities have passed GLP
compliance inspections. The clinical laboratory in the United States has
received accreditation by the College of American Pathologists. This
accreditation is the industry standard for clinical laboratories in the United
States, since the FDA has not yet adopted GLP in this area.
The industry standard for conducting clinical research and development
studies is embodied in regulations and guidelines called Good Clinical
Practices ("GCP"). Although the FDA has not formally adopted a single GCP
guideline, certain provisions of GCP have been included in FDA regulations. As
a matter of practice, the FDA and many other regulatory authorities require
that test results submitted to such authorities be based on studies conducted
in accordance with GCP. These regulations include (i) complying with FDA
regulations governing the selection of qualified investigators; (ii) obtaining
specific written commitments from the investigators; (iii) verifying that
patient informed consent is obtained; (iv) monitoring the validity and accuracy
of data; (v) verifying drug or device accountability; and (vi) instructing
investigators to maintain records and reports. The Company must also maintain
reports for each study for specified periods for inspection by the study
sponsor and the FDA during audits. Non-compliance with GCP can result in the
disqualification of data collected during the clinical trial.
The Company's facility in Edinburgh, Scotland manufactures clinical trial
supplies and thus is subject to standards of Good Manufacturing Practice
regulations ("GMP"). The GMP function of the facility is inspected biennially
by the Medicines Control Agency in the United Kingdom.
The Company's standard operating procedures are written in accordance with
regulations and guidelines appropriate to the region where they will be used.
Within Europe, all work is carried out in accordance with the European
Community Note For Guidance, "Good Clinical Practice for Trials on Medicinal
Products in the European Community." In addition, FDA regulations and
guidelines serve as a basis for the Company's North American standard operating
procedures. Both the Company's Australian and Japanese offices have developed
standard operating procedures in accordance with their local requirements and
in harmony with the Company's North American and European operations. From a
transnational perspective, the Company has implemented common standard
operating procedures across regions to assure consistency whenever it is
feasible and appropriate to do so.
EMPLOYEES
At December 31, 1995, the Company had approximately 2,000 employees.
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EXECUTIVE OFFICERS
The following table provides information on the executive officers of the
Company. There are no family relationships between any of the executive
officers or directors of the Company.
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Name Age Position with the Company
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Dennis B. Gillings, Ph.D. 51 Chairman of the Board of Directors and
Chief Executive Officer
Santo J. Costa 50 President, Chief Operating Officer and Director
Rachel R. Selisker 40 Chief Financial Officer, Vice President Finance and
Treasurer and Director
Sara B. Creagh 44 Executive Vice President and Director
William A. Sollecito, Dr.P.H. 49 President, Quintiles Americas and Director
Ludo J. Reynders, Ph.D. 42 President, Quintiles Europe, Managing Director,
Quintiles (UK) Ltd., and Director
Gregory D. Porter 39 Vice President, General Counsel and Secretary
</TABLE>
Dennis B. Gillings, Ph.D. founded the Company in 1982 and has served as
Chief Executive Officer and Chairman of the Board of Directors since its
inception. From 1972-1988, Dr. Gillings served as a professor in the
Department of Biostatistics at the University of North Carolina at Chapel Hill.
During his tenure as a professor, he was active in statistical consulting for
the pharmaceutical industry. Dr. Gillings recently has been appointed as
Trustee to the National Institute of Statistical Sciences and currently serves
on the Board of Trustees of the University of North Carolina School of Public
Health Fund. Dr. Gillings has been published widely in scientific and medical
journals. Dr. Gillings received a Diploma in Mathematical Statistics from the
University of Cambridge and a Ph.D. in Mathematics from the University of
Exeter.
Santo J. Costa became President and Chief Operating Officer of the Company
on April 1, 1994 and has been a director since April 1994. From July 1, 1993
to March 31, 1994, Mr. Costa directed the affairs of his own consulting firm,
Santo J. Costa & Associates, which focused on pharmaceutical and biotechnology
companies. Prior to June 30, 1993, Mr. Costa served seven years at Glaxo,
Inc., a pharmaceutical company, as Senior Vice President Administration and
General Counsel and a member of the Board of Directors. Mr. Costa received a
J.D. degree from St. John's University.
Rachel R. Selisker, a certified public accountant, serves as Chief
Financial Officer, Vice President Finance and Treasurer for the Company and has
been the Company's principal financial officer since 1987. She has served as a
director since November 1995. From 1981-1987, Ms. Selisker was with the
accounting firm of Oppenheim, Appel, Dixon & Co. in Raleigh, North Carolina.
Sara B. Creagh has served as Executive Vice President of the Company since
1991 and as a director since November 1995. Ms. Creagh has been associated
with the Company since 1984 and is responsible for corporate communications,
public relations, transnational committee coordination,
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marketing and human resource management. Ms. Creagh received an M.A. in
Organizational Communication from Louisiana State University.
William A. Sollecito, Dr.P.H. serves as President of Quintiles Americas
and has served as President of Quintiles, Inc. and Quintiles Pacific, Inc.,
since 1993. Dr. Sollecito has served as a director of the Company since
January 1, 1995. Dr. Sollecito has been associated with the Company since
1982. Prior to that time, he was a principal investigator and research
associate in the Department of Biostatistics at the University of North
Carolina at Chapel Hill. Dr. Sollecito received an M.S. in Biostatistics from
the University of Pittsburgh and a Dr.P.H. in Biostatistics from the University
of North Carolina at Chapel Hill.
Ludo J. Reynders, Ph.D. has served as President of Quintiles Europe since
1992 and has served as a director of the Company since January 1, 1995. Dr.
Reynders has been associated with the Company since 1988. Prior to joining the
Company, Dr. Reynders managed the biostatistics and data management department
of the Bristol-Myers Co. Pharmaceutical Research and Development Division,
located in Brussels, Belgium. Dr. Reynders received an M.S. and Ph.D. in
Applied Sciences from the University of Louvain, Louvain, Belgium.
Gregory D. Porter has served as Vice President, General Counsel and
Secretary of the Company since September 1994. From 1982 to September 1994,
Mr. Porter was in the private practice of law. From 1981 to 1982, Mr. Porter
clerked with the Honorable William Matthew Byrne of the United States District
Court for the Central District of California. Mr. Porter received his law
degree from the University of North Carolina at Chapel Hill.
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<PAGE> 13
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized, in Morrisville, North
Carolina, on the 15th day of May, 1996.
QUINTILES TRANSNATIONAL CORP.
By: /s/ Rachel R. Selisker
---------------------------------------
Rachel R. Selisker
Chief Financial Officer, Vice President
Finance and Treasurer
13
