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DATA Datrix Spa

1.445
-0.005 (-0.34%)
Last Updated: 14:38:01
Delayed by 15 minutes
Share Name Share Symbol Market Type
Datrix Spa BIT:DATA Italy Ordinary Share
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  -0.005 -0.34% 1.445 1.42 1.445 1.45 1.42 1.45 10,000 14:38:01

Another Technology Transfer Client Plans to Begin 20 Phase I Trials With DATATRAK

13/04/2005 4:14pm

PR Newswire (US)


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Another Technology Transfer Client Plans to Begin 20 Phase I Trials With DATATRAK Relationship with European Contract Research Organization, CRO Alliance, strengthens with plans to utilize DATATRAK EDC(R) in 20 Phase I trials over the next year CLEVELAND, April 13 /PRNewswire-FirstCall/ -- DATATRAK International, Inc. (Nasdaq: "DATA"), the leading and most experienced Application Service Provider (ASP) in the Electronic Data Capture (EDC) industry, today announced that CRO Alliance (CROSS s.a., CROSS Research s.a.) based in Arzo, Switzerland has given the Company specifications for 20 Phase I clinical trials to be initiated over the next year. These clinical trials will be performed in two Phase I research units located in Lugano, Switzerland and Vienna, Austria. DATATRAK and CRO Alliance have had a previous relationship that was initiated in 2004 where a master budgetary agreement was developed along with steps toward complete Technology Transfer. With the recent release of Version 4.0, CRO Alliance staff will now be trained on the most recent Version of DATATRAK EDC(R) and they will be performing all of the design and reporting aspects of these EDC clinical trials. This represents the second recently announced Technology Transfer relationship where clients are taking control of their own electronic clinical trials using DATATRAK EDC(R). The previous Technology Transfer relationship was with a North American clinical trial sponsor and this one is with a contract research organization, indicating that it is economically advantageous for both groups to become independent in the management of their own EDC studies. Technology Transfer is defined as taking the functionality of the DATATRAK EDC(TM) product suite "in-house" in order to allow customer personnel to be independent in the design and reporting aspects of their electronic clinical trials instead of outsourcing such services. This empowerment also includes exploitation of the administrative capabilities possible with the Company's clinical trial operating system, StudyTrak(TM). Technology Transfer is analogous to building one's own spreadsheets as opposed to contracting for such services. In this level of Technology Transfer, users from around the world perform all activities via the Company's ASP platform hosted by its data center in Cleveland, Ohio. Leveraging this state-of-the-art data center means that customers can immediately realize the benefits of global EDC implementations without the delays and costs involved with multimillion dollar investments in duplicating a capability that is outside of their core competency. For mid- sized to smaller pharmaceutical, biotechnology and contract research organization companies such an investment would not be a consideration. Therefore, with Technology Transfer all clients can have immediate and proven acceleration of clinical development at lower cost with an option that requires no upfront capital. All customers pursuing Technology Transfer continue to use DATATRAK's Solution Center Services located in Bonn, Germany for worldwide support of Level I Help Desk needs. Steps involved with maximizing Technology Transfer include training of project managers, data managers and medical personnel at the clinical trial sponsor or the contract research organization by DATATRAK on the product suite. This is followed by a "mentoring program" where the customer is assigned a relationship leader to guide their team through software functionality as well as the new workflows needed to maximize value with EDC compared to manual methods. Part of this training involves instruction by DATATRAK, supported through various case examples, on how to maximize investments and efficiencies in clinical research through the use of technology. This block of clinical trials is for Phase I studies, which are characteristically smaller than the average EDC project. Nonetheless, under the Technology Transfer business model, revenue to DATATRAK will likely be at a higher gross profit margin because a larger proportion of the Company's deliverables will be related to technology and support rather than from billable hours. "When customers elect Technology Transfer it represents a win-win for all constituencies", stated Dr. Jeffrey A. Green, President and Chief Executive Officer of DATATRAK International, Inc. "Clients can be in complete control and budget payments for EDC decline as they internalize activities. Service companies, like contract research organizations can brand their own e-clinical initiative and create a new revenue line for their organizations that is likely at a higher margin with greater scalability than one that is based on manually transporting and transforming paper. DATATRAK benefits because scalability issues are virtually eliminated, our margins on these trials will likely increase and we fulfill our objectives of being the pure technology provider. We envision hiring no new personnel in order to deliver on these 20 new projects." Green concluded, "Technology Transfer will be the foundation for large scale adoptions. However, everyone should remember that such transitions take time to mature. Our relationship with the CRO Alliance began almost a year ago. It is logical in this early stage for clients to move to Technology Transfer after they have had successful experiences through traditional delivery of EDC from the technology provider. After positive results, they are more inclined to then say, 'we can do this'. Once many successful Technology Transfer relationships have been launched, subsequent customers will move more quickly to this approach as there will be an established blueprint and the fears of risks will have been alleviated." About DATATRAK International 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 46 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 stock is 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 EDCÔ software; the development and fluctuations in the market for EDC technology; continued unreliability of the Internet infrastructure; 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; dependence on key personnel; 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. DATASOURCE: DATATRAK International, Inc. CONTACT: Jeffrey A. Green, Pharm.D., FCP, President and Chief Executive Officer of DATATRAK International, Inc., +1-440-443-0082, ext. 112; Terry C. Black, Chief Financial Officer of DATATRAK International, Inc., +1-440-443-0082, ext. 110; Neal Feagans, Investor Relations, Feagans Consulting, Inc., +1-303-449-1184 Web site: http://www.datatraknet.com/

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