DATATRAK International, Inc. Adds Country With South Korea; Begins Two New Trials Using EDC To SAS(R) Drug Development Connections
CLEVELAND, Jan. 19 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. , the leading and most experienced Application Service Provider ("ASP") in the Electronic Data Capture ("EDC") industry, today announced that it has added two new clinical trials with existing customers that will utilize the efficiencies of transmitting information from DATATRAK EDC(R) directly into SAS(R) Drug Development. Additionally, a third client has extended the geographic distribution of their clinical trial with sites to be located in South Korea. This will represent the 55th country in which DATATRAK EDC(R) has been deployed in clinical trials.
One of the clinical trials that will be transmitting data directly from DATATRAK EDC(R) into SAS(R) Drug Development will be using the advantages of the DATATRAK Aware(SM) - Powered by SAS offering. This client previously underwent a Technology Transfer and independently set up their trial using DATATRAK EDC(R). Through the added use of the DATATRAK Aware(SM) - Powered by SAS option, a true "end to end," integrated and web-based technology offering is being utilized in this international study -- from design to analysis -- with all steps, except Help Desk and Hosting Services, being provided by the clinical trial sponsor.
Becoming a Technology Transfer client is not necessary in order to realize the benefits of linking DATATRAK EDC(R) information directly into a repository architecture. The second trial leveraging DATATRAK EDC(R) linkages with SAS(R) Drug Development is being performed by a client that has not chosen the Technology Transfer option. The fact that both options exist indicates the flexibility possible depending upon the priorities and capacities of the customer.
DATATRAK is the first and only EDC provider that can provide automatic data integration with SAS(R) Drug Development that transmits information in a CDISC-compliant manner. CDISC stands for Clinical Data Interchange Standards Consortium, and its data models are becoming increasingly adopted in the clinical research industries. There are significant advantages for clients with this unique pre-established linkage. DATATRAK and SAS have made the investments in order to produce this efficiency for all clinical trial sponsors and contract research organizations. Additionally, all the necessary parallel upgrades of connections between both product suites and the validation of such technical requirements continue to be managed by DATATRAK and SAS at no cost to the customer.
"The implementation of clinical trials that take advantage of our integration with SAS(R) Drug Development will provide our customers with an ability to see how efficient this process can be over traditional data management and biostatistical approaches," stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. "DATATRAK has the only automatic integration capability between EDC data and SAS(R) Drug Development. Though SAS(R) Drug Development is capable of accepting many different file structures, the work that SAS and DATATRAK have accomplished to streamline that process means customers can immediately receive the benefits of aggregated research data without incurring integration costs and delays."
About DATATRAK
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(R) and related services to the pharmaceutical, biotechnology, and medical device industries. DATATRAK EDC(R) 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(R) can be deployed worldwide in either a distributed platform using laptop computers or in a centralized environment using the Internet. DATATRAK EDC(R) 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 50 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 shares are listed on the Nasdaq Stock Market under the symbol "DATA." Visit the DATATRAK International, Inc. web site at http://www.datatrak.net or http://www.datatraknet.de.
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 the DATATRAK EDC(R) software; the development and fluctuations in the market for EDC 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 EDC 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 & Chief ExecutiveOfficer, +1-440-443-0082, ext. 112, or Terry C. Black, Chief FinancialOfficer, +1-440-443-0082, ext. 110, both of DATATRAK International; orInvestor Relations, Neal Feagans of Feagans Consulting, Inc., for DATATRAKInternational, +1-303-449-1184