DATATRAK Releases Version 4.0 That Empowers Clients to Take Control of EDC Trials

DATATRAK Releases Version 4.0 That Empowers Clients to Take Control of EDC Trials

Advancements with this new version include innovative study design architecture, "push button" amendment process and unique ability to convert trials from competitors

CLEVELAND, Jan. 25 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. (NASDAQ:DATA), the leading and most experienced Application Service Provider (ASP) in the Electronic Data Capture (EDC) industry, today announced they have released Version 4.0 of the DATATRAK EDC(R) Product Suite. Version 4.0 represents significant advancements in software engineering and architecture from the most experienced Developers in the EDC industry. There are many new features of Version 4.0, but only three will be highlighted in this announcement. For a full listing of the exciting new functionalities everyone is welcome to contact the Company for a complete written description.

One of the innovative aspects of Version 4.0 includes an integrated study design architecture that will allow for an almost effortless "push button" amendment or "mid-study change" process. Amendments are commonplace because of the dynamic nature of clinical trials. The organized and premeditated structure of EDC clinical trials is what gives technology the advantage of speed over paper-based methods, but, this requirement becomes challenging when multiple alterations to a study design necessitate commensurate changes to the eventual database. Study amendments are frequently perceived to be a major difficulty of all EDC systems. Version 4.0 has solved this problem by automatically linking any changes to the electronic case report form (eCRF) directly to an appropriate reconfiguration of the database in a manner that is completely transparent to the user. Such changes in the eCRF and the database can be accomplished with Version 4.0 and placed into worldwide production in a matter of minutes. Because of the simplicity and intuitiveness of the user interface, Version 4.0 will greatly empower personnel at clinical trial sponsors to take direct control of all aspects of their EDC studies instead of requiring the vendor to institute every task.

As one of the early sponsors and supporters of the Clinical Data Interchange Standards Consortium (CDISC), DATATRAK has designed Version 4.0 to be completely compliant with the Operational Data Model (ODM), Version 1.2 from CDISC for transfers of data to and from the Company's EDC system.

Additionally, because of its open architecture, Version 4.0 will be capable of converting clinical trials begun with another EDC product over to DATATRAK EDC(R). Clients wishing to switch product suites no longer have to wait until the trial is completed before launching a new project with a different technology solution. Because of this capability, clinical trial sponsors do not have to delay receiving the unique process advantages from a direct linkage between DATATRAK EDC(R) and SAS Drug Development.

"Our previous versions quickly enabled the creation of highly dynamic electronic Case Report Forms. Version 4.0 of our study design tool will bring personnel productivity to unprecedented levels. The fastest gets faster. We are quite pleased," said Marc Shlaes, Vice President, Research and Development.

"The process advantages of Version 4.0 will be extremely significant to our customers and to our Company because scalability will be greatly enhanced," stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. "More work per unit time and per person will be able to be leveraged because of our technological advancements, making the value proposition of EDC even more compelling. Visionary development such as this will convince clinical trial sponsors that independence with the right EDC platform will produce a competitive advantage for their companies. The capabilities of Version 4.0 will save time and money for the customer and will provide a roadmap to transition job functions from a paper-based world to a technology-based future."

About DATATRAK International

DATATRAK International, Inc. is a worldwide ASP for the EDC industry. The Company provides a suite of software products supporting the use of DATATRAK EDC(R) and related services to the pharmaceutical, biotechnology, and medical device industries. DATATRAK EDC(R) was developed in order to deliver clinical research data from investigative sites to clinical trial sponsors faster and more efficiently than conventional, manual methods. DATATRAK EDC(R) can be deployed worldwide in either a distributed platform using laptop computers or in a centralized environment using the Internet. DATATRAK EDC(R) software and its earlier versions have successfully supported many international clinical studies involving thousands of clinical research sites and encompassing tens of thousands of patients in over 46 countries. DATATRAK International, Inc.'s product suite has been utilized in some aspect of the clinical development of 14 separate drugs that have received regulatory approval from either the United States Food and Drug Administration or counterpart European bodies. DATATRAK International, Inc. has offices located in Cleveland, Ohio and Bonn, Germany. Its common stock is listed on the Nasdaq Stock Market under the symbol "DATA." Visit the DATATRAK International, Inc. web site at www.datatrak.net or www.datatraknet.de .

Except for the historical 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(TM) software; the development and fluctuations in the market for EDC technology; continued unreliability of the Internet infrastructure; the degree of the Company's success in obtaining new contracts; the timing of payments from customers and the timing of clinical trial 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 EDC 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.


Source: DATATRAK International, Inc.

CONTACT: Jeffrey A. Green, Pharm.D., FCP, President and Chief Executive
Officer, ext. 112, or Terry C. Black, Chief Financial Officer, ext. 110, both
of DATATRAK International, Inc., +1-440-443-0082; or Neal Feagans, Investor
Relations, of Feagans Consulting, Inc., +1-303-449-1184

Web site: http://www.datatraknet.com/
http://www.datatraknet.de/


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