CLEVELAND, Feb. 28 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. (NASDAQ:DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, reported today that it has received a block of six cardiac safety studies from six clinical trial sponsors, as a result of its ongoing relationship with COResearch, a business unit of Duke Medical Strategies, Inc. The value of these new trials to DATATRAK is expected to be approximately $800,000. Four of these clinical trial sponsors represent new clients brought by COResearch and represent new customer exposures to the capabilities of the DATATRAK eClinical(TM) platform. One of the new clinical trials is expected to involve over 80,000 digital electrocardiograms (ECGs). Work should begin on these new clinical trials over the next couple of weeks.
"We continue to be pleased with our established alliance with COResearch, as well as their association with one of the world's leading academic medical centers," states Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. "Under our alliance, 100% of the studies COResearch wins utilizing the DATATRAK eClinical platform translate into automatic wins for DATATRAK. The leverage that DATATRAK receives in this relationship is tremendous, since all of these projects were delivered by COResearch without any necessary involvement by our sales team, thereby greatly diminishing our cost of sales. Additionally, we expect that 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." Dianne Cheesborough, COResearch Vice-President of Operations remarks, "As both a core laboratory and coordinating center, COResearch has quickly identified the benefits of utilizing a world-class data management platform. The DATATRAK eClinical(TM) platform has allowed our organization to become more competitive - by automating many of our processes - resulting in a more efficient, cost-effective environment." The COResearch organization will continue to develop its methods of data management and data application. "One of the features of the DATATRAK eClinical(TM) platform, is its flexibility," Ms. Cheesborough reflects, "The clinical trial industry is constantly changing and continuously expanding. The DATATRAK data management system is complimentary of our ability to adapt to the changing needs of the clinical trial industry. The DATATRAK platform has allowed for this flexibility to not only be feasible, but realistically applicable." COResearch's expansion of imaging services under the direction of Dr. Pamela Douglas, Director of Cardiac Safety Imaging, Duke Clinical Research Institute (DCRI), will further utilize DATATRAK's functionality. Dr. Douglas is the Ursula Geller Professor for Research in Cardiovascular Diseases at DUMC, a past president of the American College of Cardiology, and a past president of the American Society of Echocardiography. She previously served as Chief of the Division of Cardiovascular Medicine at DUMC. Dr. Douglas's applied experience and expertise will allow for COResearch's imaging services to include: echocardiography, atherosclerotic imaging-carotid intima-media thickness, cardiac nuclear imaging, cardiac magnetic resonance imaging, quantitative coronary angiography, and cardiac computed tomography.
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. DATATRAK 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. These products have allowed for clinical research data to be transmitted more quickly and 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. These trials have involved thousands of clinical research sites and encompassed tens of thousands of patients in more than 55 countries. DATATRAK International, Inc.'s product suite has 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.
The development of the DATATRAK eClinical(TM) Platform has made possible the collection of ECG and image analysis data in a global Application Service Provider (ASP) manner, which allows for remote review from a centralized reading center of the clinical trial sponsors' choosing, anywhere in the world. The ability to collect ECG and image analysis is a global ASP manner allows for the creation of a revenue line for DATATRAK's products and services. This revenue line acts in conjunction with DATATRAK's more traditional ability to create platforms for the collection, review, and storage of accompanying clinical trial information.
The collective clinical trial expertise of COResearch and DATATRAK International, Inc. has created a unique collaboration. As both organizations look to the future, they hope to continue to find creative, safe, and effective data management options. Dr. Green remarks, "Our future objectives are to sell the advantages of our unified platform and add core business from these new relationships. The importance of cardiac safety and the emphasis being placed on cardiac safety research by the FDA, will only increase research demands throughout the global clinical trials industry over the next few years." Inevitably, data management demands will intensify, as a result.
COResearch is a business unit of Duke Medical Strategies, Inc. and is located in Durham, NC on the Duke University Medical Center campus. For more information, please visit the COResearch web site (currently being revised) at http://www.coresearch.biz/ or contact: Tracey Harrill, RN
Head, Cardiac Safety
Strategic Therapeutic Development
COResearch, a business unit of Duke Medical Strategies, Inc. 919-668-7522
DATATRAK International, Inc. has offices located in Cleveland, Ohio; Bonn, Germany; and Bryan, Texas. DATATRAK's common stock is listed on the NASDAQ stock Market under the ticker symbol, "DATA." For more information, please visit DATATRAK International, Inc.'s web site at http://www.datatrak.net/ or contact: Jeffrey A. Green, Pharm.D., FCP
President and Chief Executive Officer
DATATRAK International, Inc. 440-443-0082 x 112 Ray Merk
Chief Financial Officer
DATATRAK International, Inc. 440-443-0082 x 181 Neal Feagans
Investor Relations
Feagans Consulting, Inc. 303-449-1184 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. DATASOURCE: DATATRAK International, Inc.
CONTACT: Tracey Harrill, RN, Head, Cardiac Safety, Strategic Therapeutic Development of COResearch, +1-919-668-7522, ; or Jeffrey A. Green, Pharm.D., FCP, President and Chief Executive Officer, +1-440-443-0082 x 112, or Ray Merk, Chief Financial Officer, +1-440-443-0082 x 181, both of DATATRAK International, Inc.; or Neal Feagans, Investor Relations of Feagans Consulting, Inc., +1-303-449-1184 Web site: http://www.datatrak.net/ http://www.coresearch.biz/
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