CLEVELAND, OH, and ROCHESTER, NY, February 25, 2004 – DATATRAK International, Inc. (Nasdaq: "DATA"), the leading and most experienced Application Service Provider ("ASP") in the Electronic Data Capture ("EDC") industry, and Research Dynamics, a specialty Contract Research Organization (CRO), today announced the initiation of a joint consulting offering designed to assist clinical trial sponsors in modernizing their Standard Operating Procedures (SOPs) as their organizations transition from paper-based clinical trials to EDC. DATATRAK and Research Dynamics have branded this initiative as eMerge. Such consulting activity will represent a new secondary revenue line for DATATRAK. This fulfills a commitment in a September 18, 2003 Press Release that stated this Certification Program would begin by the end of the first quarter in 2004.
This EDC Certification Program leverages the complementary strengths of DATATRAK which is focused on the delivery of global technology solutions for the e-clinical environment, and of Research Dynamics, which has an extensive reputation in the industry for the conduct of high quality, successful clinical trials, education and SOP development. These companies will contribute towards the creation of a blueprint on how SOPs should be streamlined in order to take full advantage of EDC implementations in clinical trials while eliminating time and expense of redundant activities that can persist when new technology simply overlays old process.
As the EDC market develops, it is increasingly recognized that procedures need to change with the implementation of technology in order for maximal value to be realized. As a simple example, since EDC provides for immediate access to worldwide clinical trial data, it is not necessary to physically travel to research sites as frequently in order to view or directly comment on such information. With EDC, data assessments can be accomplished remotely using secure technology platforms with incumbent audit trails that provide far greater reliability, legibility and archival traceability than traditional paper methods. However, since SOPs govern organizational behavior, especially in a regulated field such as clinical trials, upgrading of SOPs is necessary in order to establish procedures that are efficient and compliant. The goal of eMerge is to assist customers in advancing their SOPs in order to properly leverage technology and eliminate redundancy. This will position their organizations to fully realize the value of EDC.
Lorraine D. Ellis, President and Chief Executive Officer of Research Dynamics believes the eMerge Certification Program represents a major paradigm shift in the conduct of clinical trials. "It is apparent that the inefficiency and lack of control inherent in most clinical trials conducted today is a significant problem. The eMerge program has evolved from our combined vision to deliver more reliable, cleaner data faster and more cost-effectively. We are proud to partner with DATATRAK on this important initiative, and feel that this paradigm has the potential to become an industry standard in the not so distant future."
"We have identified a real need for eMerge and we are excited about launching this with a team as experienced as Research Dynamics," noted Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. "Every one of our customers sees the importance of this Program. Several have already set up meetings with their staff and CROs regarding EDC Certification. SOPs are the key to eMerge because if old processes continue to be sanctioned by operating procedures that are inconsistent with new capabilities, staffs have a reason not to change their behavior and the value proposition is undermined or diluted."
Green continued, "The reason for Certification is exemplified by many of our ongoing clinical trials where thousands of data fields go completely unreviewed for as much as six months because clinical monitoring staffs are waiting for a scheduled physical visit before even looking at the information. Such gaps in what we have termed 'data awareness' for an investigational drug or device obviously impact reaction time and could affect overall patient safety, because what you don't know, you can't assess. These gaps in awareness can be easily rectified with EDC while simultaneously reducing the time and cost of product development. Upon review of information such as this, customers have decided to take the steps towards EDC certification."
Research Dynamics, founded in 1993, is a privately held CRO conducting Phase I-IV clinical trials for the pharmaceutical, biotechnology, and medical device industries. The company conducts training courses throughout the country, and provides training aids and products for clinical research professionals. Research Dynamics specializes in providing high quality clinical research services cost-effectively through the use of leading edge technology and experienced people. The company, headquartered in Rochester, NY, has been named a "Rochester Top 100 Company" for the past two years. To learn more, visit the Research Dynamics website at www.resdyncg.com
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 and related services to the pharmaceutical, biotechnology, and medical device industries. DATATRAK EDC 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 can be deployed worldwide in either a distributed platform using laptop computers or in a centralized environment using the Internet. DATATRAK EDC 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 over 40 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 stock is listed on the Nasdaq Stock Market under the symbol "DATA." Visit the DATATRAK International, Inc. web site at www.datatraknet.com or www.datatraknet.de