CLEVELAND, Oct. 21 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. , the leading and most experienced Application Service Provider (“ASP”) in the Electronic Data Capture (“EDC”) industry today announced that it will initiate its second eMerge(SM) consulting relationship with a European-based pharmaceutical company that previously selected DATATRAK EDC(R) for Enterprise deployment in their clinical trial programs. DATATRAK is currently completing its first eMerge(SM) engagement with an American-based pharmaceutical company which also underwent a Technology Transfer with the product suite.
eMerge(SM) is a consulting program designed to help clinical trial sponsors advance and refine their workflow and contracting process when EDC is used in place of traditional paper methods. Many processes change with EDC ranging from monitoring activities to the structure of contracts with related service providers. During implementation of the eMerge(SM) Program, DATATRAK works closely with clinical, data management, quality assurance and contracting teams at the client in order to customize how procedures should be advanced when technology is the mechanism by which information is collected, reviewed and transmitted. The goal of eMerge(SM) is to provide the clinical trial sponsor with a complete set of “e-SOPs” (Standard Operating Procedures) that can be utilized to deliver the maximal amount of cost-effectiveness and acceleration of drug development when data collection and review is performed using the Internet.
“We are pleased to have another client recognize the value of our eMerge(SM) consulting program”, stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. “We believe that eMerge(SM) will be increasingly viewed as important by clinical trial sponsors as they transition a greater number of clinical trials from paper to EDC. The delivery of eMerge(SM) provides a significant level of credibility for our Company as our customers look to our experience in order to help them design the most efficient e-clinical process for their organizations. Since eMerge(SM) requires a reorganization of clinical trial procedures, committing to this program likely signifies plans to establish a long-term, expanded relationship utilizing DATATRAK so that the obvious investment of time, money, personnel and strategy can be leveraged across multiple clinical trial programs.”
About DATATRAK
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 50 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 shares are 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(R) software; the development and fluctuations in the market for EDC 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 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.
DATATRAK International, Inc.
CONTACT: Jeffrey A. Green, Pharm.D., FCP, President & Chief ExecutiveOfficer, +1-440-443-0082 x112, or Terry C. Black, Chief Financial Officer,+1-440-443-0082 x110, both of DATATRAK International; or Neal Feagans,Investor Relations of Feagans Consulting, Inc, +1-303-449-1184
