CLEVELAND, April 21 DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced that DATATRAK eClinical's(TM) safety components have been expanded to include additional exporting capabilities. The new safety tools include an exchange between investigational sites and safety reporting systems. The DATATRAK eClinical(TM) Safety Export provides a unified process for transferring serious adverse events (SAEs) and related data from clinical sites to safety systems.
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The time and paper intensive process of exchanging data between sites, sponsors and regulatory authorities creates inefficiencies in the safety reporting process. DATATRAK eClinical's(TM) Safety Export expands the system's capabilities to transfer safety case data from clinical sites to centralized safety reporting systems using the industry standard E2B format. The Safety Export capitalizes on the efforts already performed by sites through eliminating the need for duplicate data entry into a safety system. The resulting benefits include fewer reporting errors, compressed timelines and a reduction in costs associated with database reconciliation. In addition to supporting the International Conference on Harmonization's (ICH) standard E2B file format, the Safety Export can also support mapping to a sponsor's internal standards. The system's flexibility allows for consolidation of processes across multiple fronts.
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"The DATATRAK eClinical(TM) Safety Export will simplify a clinical site's work effort and demonstrate improvements in the overall safety reporting process," said Chris Wilke, Chief Technology Officer of DATATRAK. "The Safety Export is our first step in addressing safety reporting issues for our clients; the next step will be a summer release of our Safety System. As we move forward with our single database, unified solution, we look forward to solving safety data reconciliation challenges in ways never before achieved."
About DATATRAK International, Inc.
DATATRAK International, Inc. is a worldwide technology and services company focused on the provision of multi-component eClinical solutions and related services for the clinical trials industry. We operate under the vision of DATATRAK ONE(TM), which encompasses our unique, single platform technology. The singular architecture of our DATATRAK eClinical(TM) product suite has been embraced by clients around the globe for its ability to effectively manage clinical trials through a unified multi-component, comprehensive solution. 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 appropriate regulatory agency, faster and more efficiently than manual methods or loosely integrated technologies. DATATRAK's eClinical(TM) software suite can be deployed worldwide through an ASP offering or in a licensed Enterprise 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 59 countries. DATATRAK International, Inc.'s product suite has been utilized in some aspect of the clinical development of 16 drugs and one medical device 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 Bryan, Texas. 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. These forward-looking statements are made based on management's expectations, assumptions, estimates and current beliefs concerning the operations, future results and prospects of the Company and are subject to uncertainties and factors (including those specified below) which are difficult to predict and, in many instances, are beyond the control of the Company. Factors that may cause actual results to differ materially from those in the forward-looking statements include the limited operating history on which the Company's performance can be evaluated; the ability of the Company to continue to enhance its software products to meet customer and market needs; fluctuations in the Company's quarterly results; the viability of the Company's business strategy and its early stage of development; the timing of clinical trial sponsor decisions to conduct new clinical trials or cancel or delay ongoing trials; the Company's dependence on major customers; government regulation associated with clinical trials and the approval of new drugs; the ability of the Company to compete in the emerging EDC market; losses that potentially could be incurred from breaches of contracts or loss of customer data; the inability to protect intellectual property rights or the infringement upon other's intellectual property rights; and general economic conditions such as the rate of employment, inflation, interest rates and the condition of capital markets. This list of factors is not all-inclusive. 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. The Company undertakes no obligation to update publicly or revise any forward-looking statement whether as a result of new information, future events or otherwise.
SOURCE DATATRAK International, Inc.
