CLEVELAND, July 7 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. , a technology and services company focused on global eClinical solutions for the clinical trials industry, today reported that over the past week it has received a block of five cardiac safety studies from five new clients as a result of its previously announced relationship with COResearch, Inc., a division of Duke Medical Strategies. The value of these new contracts to DATATRAK is expected to be approximately $250,000 and will bring the total number of projects being performed for COResearch to seven involving seven different clinical trial sponsors. All of these new clients brought by COResearch represent new customer exposures to DATATRAK eClinical(TM). This new group of five international clinical trials will be performed in approximately 5,200 patients. Three of the clinical trials involve safety assessments of drugs in the areas of oncology and infectious disease. The other two trials represent studies involving medical device assessments in cardiovascular abnormalities.
Four of the clinical trials will be cardiac safety studies involving electrocardiographic (ECG) tests of QT intervals, as required by the FDA. The fifth clinical trial will involve image analysis using echocardiograms, which are also known as cardiac ultrasounds. The ability to collect and allow image analysis in a global ASP (application service provider) manner is a unique advantage of the new DATATRAK eClinical(TM) platform in the clinical trials marketplace allowing for remote review anywhere in the world from a centralized reading center of the clinical trial sponsors' choosing. DATATRAK recently developed a new business model for such imaging studies as part of its unified platform and this capability adds yet another revenue line to the Company's products and services. This model contains the traditional transaction-based fee for each echocardiogram along with a price for the storage of this information in the Company's global data center.
"We are extremely pleased with the rapid results of our established alliance with COResearch," stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. "We have developed a very open relationship between the two organizations and are excited about the growing depth of their pipeline. It is impressive that in a short time COResearch has been selected as a preferred provider of cardiac safety work at several of the world's leading pharmaceutical companies. Under our alliance, 100% of the studies COResearch wins translate into automatic wins for DATATRAK. The leverage that DATATRAK receives in this relationship is tremendous, since all of these clients were delivered by COResearch without any involvement by our sales team. Additionally, the customers who have selected COResearch as a preferred provider for their cardiac safety work will eventually become users of the cardiac safety components of the DATATRAK eClinical(TM) platform, thereby extending our reach in the global marketplace. Since these cardiac safety studies often are performed as part of a broader clinical trial where other data is collected, our future objectives are to sell the advantages of our unified platform and add core business from these new relationships. Though these initial trials are modest in size, the importance of cardiac safety and the emphasis being placed on such by the FDA through established legislation will only increase this type of activity throughout the global clinical trials industry over the next few years. All of these factors continue to make us very excited about the new and unique capabilities of our extended products and services and indicate significant potential for a growing revenue line as we progress through the coming months and years."
Green concluded, "On a related note, a customer using our long-established DATATRAK EDC(R) Version 4.0 product suite recently received a drug approval from the FDA following the completion of a pivotal clinical trial. This represents the 16th drug approval from a regulatory body where our product suite provided clinical trial information as part of a development program. This is likely an industry record."
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 Technology 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 56 countries. DATATRAK International, Inc.'s product suite has been utilized in some aspect of the clinical development of 16 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, 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. 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 its software; the development and fluctuations in the market for clinical trial technology; 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; governmental regulation; the early stage of the Company's 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.
DATATRAK International, Inc.CONTACT: Jeffrey A. Green, Pharm.D., FCP, President and Chief ExecutiveOfficer, +1-440-443-0082, ext. 112, or Terry C. Black, Chief FinancialOfficer, +1-440-443-0082, ext. 110, both of DATATRAK International, Inc.;or Investor Relations, Neal Feagans of Feagans Consulting, Inc.,+1-303-449-1184
Web site: http://www.datatrak.net/
