CLEVELAND, March 22 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. , a technology and services company focused on global eClinical solutions for the clinical trials industry, today reported that it has released Version 2.5 of the DATATRAK eClinical(TM) Platform and completed the first step of its Enterprise Transfer Initiative. The release was in conjunction with the Annual DATATRAK European and U.S. User’s Group Meetings in February in Mallorca, Spain and Miami Beach, Florida. DATATRAK coordinated the release with the establishment of a Product Advisory Council (PAC) made up of leading sponsor clients.
The next evolution of the DATATRAK eClinical(TM) Platform provides even greater software performance and functionality along with improved processes and systems infrastructure to streamline the entire clinical trial process, from protocol development to warehousing of all clinical trial data and images. The Company’s multicomponent, unified platform was enhanced to leverage the capabilities of a new 64-bit high-performance three-tier computing environment. This new system provides the functionality of eClinical in a load-balanced Oracle Application Server environment managing data in an Oracle Real Application Cluster 10G database cluster and EMC2 storage solution. The release includes optimized internal software development life cycle processes and automated software testing to create a rapid development environment designed to support a quarterly product release schedule.
With this new release, the production environment at the Company’s global data center has been increased by 300% for the eClinical Platform in order to accommodate the pipeline of clinical trials expected to be deployed in 2007 and beyond.
The purpose of the PAC is to work closely with DATATRAK on the stepwise creation of functionality that will encompass the entire clinical trial process from protocol development to e-submission-ready tabulations with the goal of expediting our clients’ drug or device approvals. Our goal is to have this uniquely done within a solitary database environment obviating the need to accumulate information from separate applications, which only increases the cost and time of these efforts for our customers. We are working hard with our clients to make DATATRAK eClinical(TM) the “Desktop” for clinical trials for drugs and devices.
DATATRAK also recently completed the first step along the pathway of full Enterprise Transfer, which will empower its clients to be able to take complete electronic control of their own clinical trials through the Company’s state-of-the-art ASP (Application Service Provider) delivery and business model. This first step allows clients to configure their clinical trials remotely in a version-controlled manner satisfying full regulatory compliance using the broadest eClinical information platform in the industry. Full Enterprise Transfer is to be unveiled at this year’s Annual Drug Information Association Meeting in June in Atlanta, Georgia. DATATRAK is already training the first Enterprise Transfer client on a global scale using the eClinical Platform which is being spearheaded by the Company’s Enterprise Consulting Group. Other standardization clients are expected to embark upon Enterprise Transfer training throughout the remainder of 2007.
“This was an outstanding effort by all teams at DATATRAK to continue development of the eClinical Platform at an aggressive pace,” stated Mr. Jim Bob Ward, Vice President of Research and Development for DATATRAK International, Inc. “This overall system advancement combined with the PAC collaboration and leadership will provide the foundation for supporting our enterprise companies now and well into the future.”
Marc Shlaes, DATATRAK’s Vice President of Product Strategy added: “Via the PAC, DATATRAK is enjoying an unprecedented level of involvement by our clients. With their guidance, we are confident that our solutions will continue to lead the eClinical marketplace by growing in depth and breadth in a manner consistent with their goals and strategies.”
“Our rapid development cycle that is possible with the ‘building block’ architecture of the DATATRAK eClinical(TM) Platform will allow us to be as responsive as possible to the increasing requirements of our clients,” stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. “The combination of the PAC with our innovative development process is an excellent combination to continue DATATRAK’s leadership position with the most innovative and modern product suite in the clinical trials industry. Enterprise Transfer is clearly a future direction for this industry that is gaining momentum. As the electronic clinical trial movement grows, it is predictable that sponsors and Contract Research Organizations will want the option to take control of their internal processes and make their organizations as competitive as possible in a cost-effective manner. Our Enterprise Transfer Program, combined with our consulting efforts supporting such implementations is fundamental to drive this market forward.”
DATATRAK International, Inc. is a worldwide technology company focused on the provision of multi-component eClinical solutions and related services for the clinical trials industry. The Company delivers a complete portfolio of software products that were created in order to accelerate clinical research data from investigative sites to clinical trial sponsors and ultimately the FDA, faster and more efficiently than manual methods or loosely integrated technologies. DATATRAK’s eClinical software suite can be deployed worldwide through an ASP offering or in a licensed Enterprise Transfer model that fully empowers its clients. The DATATRAK software suite and its earlier versions have successfully supported hundreds of international clinical trials involving thousands of clinical research sites and encompassing tens of thousands of patients in 59 countries. DATATRAK International, Inc.'s product suites have been utilized in some aspect of the clinical development of 16 separate drugs and one medical device 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, Bonn, Germany, and Bryan, Texas. Its common stock is listed on the NASDAQ stock Market under the ticker symbol “DATA”. Visit the DATATRAK International, Inc. web site at www.datatrak.net.
Except for the historical information contained in this press release, the statements made in this release are forward-looking statements. These forward-looking statements are made based on management’s expectations and beliefs concerning future events impacting the Company and are subject to uncertainties and factors (including those specified below) which are difficult to predict and, in many instances, are beyond the control of the Company. Factors that may cause actual results to differ materially from those in the forward-looking statements include the limited operating history on which the Company’s performance can be evaluated; the ability of the Company to continue to enhance its software products to meet customer and market needs; fluctuations in the Company’s quarterly results; the viability of the Company’s business strategy and its early stage of development; the timing of clinical trial sponsor decisions to conduct new clinical trials or cancel or delay ongoing trials; the Company’s dependence on major customers; government regulation associated with clinical trials and the approval of new drugs; the ability of the Company to compete in the emerging EDC market; losses that potentially could be incurred from breaches of contracts or loss of customer data; the inability to protect intellectual property rights or the infringement upon other’s intellectual property rights; the Company’s success in integrating its recent acquisition’s operations into its own operations and the costs associated with maintaining and/or developing two product suites; and general economic conditions such as the rate of employment, inflation, interest rates and the condition of capital markets. This list of factors is not all inclusive. 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. The Company undertakes no obligation to update publicly or revise any forward-looking statement.
DATATRAK International, Inc.
CONTACT: Jeffrey A. Green, Pharm.D., FCP, President and Chief ExecutiveOfficer, 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, Feagans Consulting, Inc, +1-303-449-1184
Web site: http://www.datatrak.net/
