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Securities and Exchange Commission
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report JUNE 26, 1999
(Date of earliest event reported)
DATATRAK INTERNATIONAL, INC.
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(Exact name of registrant as specified in its charter)
Ohio (000-20699) 34-1685364
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(State or other jurisdiction (Commission File No.) (I.R.S. Employer
of incorporation) Identification No.)
20600 Chagrin Boulevard, Cleveland, Ohio 44122
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (216) 921-6505
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Page 1 of 5 Pages
Exhibit Index Appears on Page 3
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Item 5. Other Events
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On June 26, 1999, DataTRAK International, Inc. (the "Company") signed a
3-year, software license and master services agreement with Quintiles, Inc.
("Quintiles"). The software agreement is mutually nonexclusive between the
Company, a leader in worldwide use of Electronic Data Capture ("EDC") and
Quintiles, the Product Development service group of Quintiles Transnational
Corp., the leading healthcare services company to the pharmaceutical industry.
The software-licensing portion of the agreement grants Quintiles unlimited use
of the Company's five DataTRAK modules, namely: DataTRAK Design(TM), DataTRAK
Entry(TM), DataTRAK Review(TM), DataTRAK Report(TM), and DataTRAK Export(TM).
The Company will also train, educate and provide help desk assistance to
Quintiles employees, investigative site personnel, and sponsor representatives.
SIGNATURE
Pursuant to the requirements 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.
DataTRAK INTERNATIONAL, INC.
By: /s/ Terry C. Black
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Terry C. Black
Vice President of Finance, Chief Financial
Officer, Treasurer and Assistant Secretary
Date: July 8, 1999
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EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION PAGE
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99.1 Press Release Issued by the Company
on June 30, 1999. 4
Page 3 of 5 Pages
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE:
DATATRAK AND QUINTILES SIGN AGREEMENT FOR DEPLOYMENT OF DUAL PLATFORM
ELECTRONIC DATA CAPTURE TECHNOLOGY
CLEVELAND, OHIO, June 30, 1999 DataTRAK International, Inc. (Nasdaq: DATA) today
announced a worldwide, 3-year, software license and master services agreement
with Quintiles, Inc. The software agreement is mutually nonexclusive between
DataTRAK, a leader in worldwide use of Electronic Data Capture (EDC) and
Quintiles, Inc., the Product Development service group of Quintiles
Transnational Corp. (Nasdaq: QTRN), the leading healthcare services company to
the pharmaceutical industry.
DataTRAK EDC(TM) software can be deployed through a dual platform involving
distributed laptops or via the Internet using a centralized server environment
through DataTRAK's Cleveland, Ohio, and Bonn, Germany facilities. Both platforms
can be utilized simultaneously in the same clinical trial allowing this EDC
solution to run anywhere in the world.
The software-licensing portion of the agreement grants Quintiles unlimited use
of DataTRAK's five modules, namely: DataTRAK Design(TM), DataTRAK Entry(TM),
DataTRAK Review(TM), DataTRAK Report(TM), and DataTRAK Export(TM). DataTRAK will
also train, educate and provide help desk assistance to Quintiles employees,
investigative site personnel, and sponsor representatives.
DataTRAK International's President & CEO, Dr. Jeffrey A. Green said: "It has
been our focus for the past nine months to establish a key relationship with an
anchor client in order to enhance the value of our product offering to the
marketplace and to our shareholders. We would welcome additional companies as
part of this effort over the next one to two years as EDC begins to become the
preferred expedient and cost-effective method of collecting and transferring
clinical research data throughout the industry."
Dr. Green added: "We believe that our persistence and continued investment in
the DataTRAK initiative has begun to demonstrate value enhancement for our
shareholders and represents a new and exciting phase for our Company. We have
begun our first EDC clinical trial with Quintiles and we look forward to
establishing a long and productive relationship."
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The Company provides a suite of electronic data capture (EDC) software products
known as DataTRAK EDC(TM) and related services to the pharmaceutical,
biotechnology, and medical device industries. DataTRAK EDC(TM) was developed in
order to deliver clinical research data from investigative sites to sponsors
faster and more efficiently than conventional manual methods. DataTRAK EDC(TM)
can be deployed worldwide in either a distributed platform using laptops or in a
centralized server "thin client" environment using the Internet. DataTRAK
EDC(TM) software and its earlier versions have successfully supported more than
31 clinical studies encompassing over 500 clinical sites and 17,000 patients.
DataTRAK International, Inc. has offices located in Cleveland, Ohio and Bonn,
Germany. Visit the DataTRAK web sites at www.datatraknet.com and
www.datatraknet.de.
Except for the historical financial information contained in this press release,
the statements made in this release are forward looking statements. Factors that
may cause actual results to differ materially from those in the forward looking
statements include the ability of the Company to absorb corporate overhead and
other fixed costs in order to successfully market the DataTRAK EDC( software;
the development and fluctuations in the market for electronic data capture
technology; the degree of the Company's success in obtaining new contracts; the
timing of payments from sponsors and the timing of sponsor decisions to conduct
new clinical trials or cancel or delay ongoing trials; dependence on key
personnel; governmental regulation; the early stage of the Company's DataTRAK
business and operations; and general economic conditions. In addition, the
Company's success depends on the outcome of various strategic initiatives it has
undertaken, all of which are based on assumptions made by the Company concerning
trends in the clinical research market and the health care industry.
CONTACT:
Jeffrey A. Green, Pharm.D., FCP Terry C. Black
President and Chief Executive Officer Chief Financial Officer
DataTRAK International, Inc. DataTRAK International, Inc.
216/921-6505 ext 112 216/921-6505 ext 110
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