CLEVELAND and GAVA, Spain, Nov. 17 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. , a technology company focused on global eClinical solutions for the clinical trials industry, today reported that a new European pharmaceutical client, GP-Pharm, has selected the Company’s software as their preferred enterprise information platform for their clinical trials. DATATRAK has been awarded the first block of five clinical trials from the companies’ pipelines that are initially expected to involve a total of 730 patients and 145 clinical research sites. These five clinical trials are being performed with the DATATRAK EDC(R) Version 4.0 product suite and are expected to be completed in the next 14 months. Subsequent clinical trials from these clients will be performed with the DATATRAK eClinical(TM) platform. This new relationship represents the seventh instance in 2006 where customers are awarding blocks of clinical trials to DATATRAK under either a global master services agreement or enterprise business model structure.
“We trust that DATATRAK is going to help us to complete successfully our next 5 pivotal clinical trials,” stated Dr. Antonio Parente, President and Chief Executive Officer of GP-Pharm. “Now we are working with DATATRAK in our phase III clinical trial of the new Leuprolide 3.75 mg depot formulation and soon we will begin in U.S. the clinical trial with a 3 months formulation (Leuprolide depot 11.25 mg). The next project will be related with the new Liposomal formulation of doxorubicin hydrocloride, Sarcodoxome(TM), which has received EU orphan drug status for the treatment of Soft Tissue Sarcoma. The new product patented by GP-Pharm, differs from other liposomal formulations as the active substance is placed in the wall of the liposome and not inside, and it contains a small percentage of chromane, a molecule with antioxidant properties that stabilized the liposome. This leads to a liposome with reduction of toxicity, greater distribution and better availability of the doxorubicin.”
“We are pleased to be selected as the preferred clinical trials technology provider for GP-Pharm and Lipotec, which further deepens our penetration in the European market,” stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. “The ordering of blocks of clinical trials under an enterprise business model structure represents another example of the stepwise progression of this market away from the inefficiencies and higher costs of the ‘trial-by-trial’ behavior that had previously been the only means of contracting for electronic clinical trials. The predictability of pricing and the ability to accelerate clinical trial launches and performance through a consistently applied information platform across an organization will lead innovative sponsors to significant competitive advantages with their R & D process and also provides excellent visibility for the technology provider in order to plan for timely delivery of products and services.”
GP-Pharm is a pharmaceutical company established in 2001 within the Lipotec Group. The company is undertaking the pharmaceutical and clinical development of products for use within the fields of Urology and Oncology based on the use of its own technological platforms of controlled release and encapsulation technologies such as Microspheres and Liposomes for injection, Coated Bioadhesive Microparticles and freeze dried liposomes for oral route absorption. Recently the new GP-Pharm Manufacturing (6000 m(2)) plant obtained the certificate of GMP compliance in the EU to manufacture injectable dosage forms, sterile drugs and other pharmaceutical forms of the own brand and also to contract manufacture for customers. Visit the GP-Pharm website at www.gp-pharm.com.
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 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 16 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 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 and beliefs concerning future events impacting 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 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, x112, or Terry C. Black, Chief Financial Officer, x110, ofDATATRAK International, Inc., +1-440-443-0082; or Neal Feagans, InvestorRelations of Feagans Consulting, Inc., +1-303-449-1184
