CLEVELAND, July 28 DATATRAK International, Inc., a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced that a European Division within a Global Top 20 Pharmaceutical organization has selected DATATRAK's eClinical(TM) Solution to conduct a Phase III clinical trial. DATATRAK has executed a letter of intent with one of the world's leading global clinical research organizations (CRO) to begin trial services immediately. With subjects to be enrolled in almost a dozen European countries, the Sponsor will be utilizing DATATRAK eClinical's web-based patient randomization, auto-coding and laboratory data import solutions in addition to its Electronic Data Capture (EDC) product to efficiently manage the study.
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"We are extremely delighted to have been awarded this important clinical project. It is very encouraging to see a Top 20 pharmaceutical company selecting the DATATRAK team," said Laurence Birch, DATATRAK's President and CEO. "This is yet another example of DATATRAK's recent resurgence in the marketplace, and I am confident that the DATATRAK eClinical(TM) Solution, as well as the operational team responsible for the project, will exceed all expectations."
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About DATATRAK International, Inc.
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 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; the costs associated with maintaining and/or developing two product suites; 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.
