DATATRAK International, Inc.'s ECG Laboratory Component Of The eClinical Platform Selected By Duke Business Unit
CLEVELAND, Ohio and DURHAM, N.C., March 15 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. , a technology company focused on global eClinical solutions for the clinical trials industry, today reported it has been selected by COResearch, a business unit of Duke Medical Strategies, Inc. as a preferred technology provider for digitized electrocardiograms (ECGs) and other core laboratory constituents that constitute their clinical trial cardiac safety offering. As part of this relationship, DATATRAK will provide a regulatory-compliant infrastructure for delivering annotated cardiac safety transactions, including ECGs and other core lab services, such as Holter recordings and echocardiographic image assessments. DATATRAK can deliver its software and related capabilities as an Application Service Provider (ASP), allowing for long-term storage, review and retrieval of these multiple laboratory tests as a service for its customers.
DATATRAK eClinical was selected as a platform by COResearch based upon a comparison of several other providers. A major factor in this decision was DATATRAK's flexible business model involving transactional-based pricing instead of seat licenses, the ability to seamlessly include other information in an eClinical platform and because of the opportunity for technology transfer that empowers the individual core laboratory with the Company's product suite that allows for branding. DATATRAK receives a transactional- based fee for each cardiac test that is performed. In this relationship, DATATRAK and COResearch are ramping up with four initial clinical trials with multiple outstanding proposals.
ECGs are tests commonly performed in most clinical trials as part of the initial screening information for eligibility of the individual patient in any given protocol. Depending upon the type of clinical trial that is being performed, multiple cardiac tests, including ECGs, Holter monitor studies and echocardiograms, before, during and after treatment may be required for every patient enrolled in the clinical trial.
The Company recently broadened its technology platform with an overall eClinical product suite. The capabilities described in this announcement are just one example of how this new platform can be immediately put into practice. The advantages for the Company's broadened customer base is that all the information involved with the clinical trial, including each patient's cardiac image or ECG, can be easily retrieved and stored within the same product suite, along with all of the accompanying clinical trial data traditionally obtained with just EDC (electronic data capture) alone. For customers selecting DATATRAK eClinical, there is no piecing together of data from multiple applications with several different vendors.
All transactions with the DATATRAK eClinical Product Suite can be delivered in a variety of formats, including SAS, Text, Excel, XML and HL7. Each core lab service can be customized using the flexible nature of DATATRAK eClinical technology, to meet the cardiac safety needs of each sponsor company. The DATATRAK Core Lab capability is a unified component of DATATRAK eClinical, providing a single end to end solution for managing a clinical trial.
COResearch is a proven global cardiovascular research organization based in one of the leading heart centers in the world, Duke University Medical Center and Duke Clinical Research Institute. This organization possesses 23 years of core lab experience with 10 Duke Faculty cardiologists and more than 14 million archived ECGs.
"DATATRAK's eClinical Product Suite provides an excellent opportunity for COResearch to utilize cutting edge technology that provides timely and cost- efficient clinical trial services to the pharmaceutical industry," stated Dr. Chris Cabell, Chief Executive Officer of COResearch. "The opportunity to work closely with an outstanding technology provider will enable COResearch to remain focused on cardiac safety evaluations while leveraging the eClinical suite to provide highly efficient and customized services to our pharmaceutical partners. The relationship between COResearch and DATATRAK will help transform the industry from reacting to market forces to focusing on delivering high quality scientific and clinical trial data that maximizes timely and complete safety evaluations."
"We are very pleased to begin this new relationship with COResearch in the important area of cardiac safety monitoring," stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. "This is just the first tangible example of the significant advantages provided to our Company and our customers from the complete set of unified functionalities embodied in our new platform represented by DATATRAK eClinical. Because of our recent transaction, we were able to immediately capitalize on high margin revenue that is additive to our core EDC business and we were able to acquire new relationships directly as a result of our expanded products and services. Importantly, we believe that our broad list of capabilities will yield synergistic activity in the marketplace giving customers significant advantages and efficiencies from collecting and storing their information in a single platform."
COResearch is a business unit of Duke Medical Strategies, Inc. and it expands upon the long history of cardiovascular safety research conducted at the Duke Clinical Research Institute (DCRI). Founded in 1983 by Dr. Mitchell Krucoff, COResearch (the former Duke eECG Core Lab) has grown in to one of the largest, most experienced ECG core laboratories in the world. COResearch not only expands the core laboratory's operational capabilities, but extends its global digital functionality beyond static and continuous ECG measurements to imaging modalities such as echocardiography. The Duke ECG Core Laboratory and COResearch have supported regulatory submissions for numerous new drugs, biologics, and medical devices. Scientific and academic leadership within COResearch has driven new initiatives in cardiac safety, as well as digital device design and concepts for optimizing measurements to support novel, efficient safety and efficacy determinations. Visit the COResearch web site at http://www.coresearch.biz.
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 conventional, manual methods. DATATRAK's 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 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, 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 http://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, Terry C. Black, Chief Financial Officer,+1-440-443-0082 ext. 110, both of DATATRAK International, Inc.; or NealFeagans, Investor Relations of Feagans Consulting, Inc, +1-303-449-1184;Dr. Christopher Cabell, Chief Executive Officer, COResearch,+1-919-668-7524