CLEVELAND, August 14 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. , a technology company focused on global eClinical solutions for the clinical trials industry, today reported that its unified platform has been selected by a multi-billion dollar North American clinical trial sponsor with the objective of standardizing their international product development efforts on this single architecture. This relationship represents another new client for DATATRAK and is the fourth customer in 2006 that has decided to exclusively deploy the Company's product suite for an entire multi-year pipeline of clinical trials. The selection of DATATRAK eClinical(TM) was made following an extensive evaluation of the world's leading clinical trial technology providers which lasted several months and culminated in a detailed technology audit of DATATRAK's capabilities and compliance with regulatory guidelines.
Work on the first 8 projects is to begin in 2006. This group of trials together with process consulting by DATATRAK has a combined initial budgetary value estimated to exceed $1 million. This client has also stated goals of initiating a large number of additional clinical trials during 2007 and beyond, some of which represent larger-sized projects. The expected number and budgetary estimates of the additional trials will be finalized in the coming quarters, at which time, more details will be provided. A Master Agreement is currently being finalized by both parties that will serve as the template for all future statements of work for individual clinical trial awards.
As another positive sign of the existence of a long-term commitment and working relationship with DATATRAK, this sponsor has stated a willingness to employ DATATRAK's consulting capabilities with its eMerge Program in order to design the proper workflows and Standard Operating Procedures for a complete eClinical trial program. DATATRAK is also working closely with the sponsor on the most efficient processes and workflows that can be used with Contract Research Organizations (CROs) that the sponsor may select to provide additional services in conjunction with eClinical deployments as part of their clinical trial programs.
DATATRAK eClinical(TM) was chosen because of its unique position in the market of having the broadest and the most unified platform of capabilities existing under one software architecture obviating the need for expensive and risky integration procedures involved with databases residing in unrelated applications. It represents the only clinical trial technology that can collectively house information obtained from electronic case report forms, electrocardiographic- and/or image-generated media associated with increasingly important cardiac safety initiatives and also can facilitate critically important and timely workflow priorities under one interrelated platform.
"We are very pleased to add the fourth customer to a growing list of companies that have selected DATATRAK eClinical(TM) as their platform for all future clinical trials," stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. "This is the type of market maturation that we highlighted in our recent conference call whereby clients are implementing blocks of clinical trials at a time from their pipeline. Such a process saves in repetitive contracting efforts and likely contributes to enhanced development productivity, but only occurs when a single standard platform is chosen rather than bouncing from vendor to vendor. This client is especially significant because of their size and the fact that they view DATATRAK as a service provider with an enterprise information platform that is capable of fulfilling their blueprints for growth. The ability to unify all clinical trial data is without a doubt the main reason for these commitments. This client adds to our already firm foundation for achieving our stated goals over the next several years of having four to five anchor clients that are capable of initiating 30-40 new clinical trials each year with DATATRAK eClinical(TM)."
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 http://www.datatrak.net .
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 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, +1-440-443-0082 ext. 112, or Terry C. Black, Chief FinancialOfficer, +1-440-443-0082 ext. 110, both of DATATRAK International, Inc.; orInvestor Relations, Neal Feagans of Feagans Consulting, Inc for DATATRAKInternational, Inc., +1-303-449-1184
Web site: http://www.datatrak.net/
