Target Health Unveils Target e*CRF Version 3; Newest Version of the Company’s Internet-Based Clinical Trial Software Enables Flexible Program Configuration and Provides Innovative Systems Development and Maintenance
Target Health Inc., an industry-leading CRO, announced the availability of the newest release of its innovative eClinical trial software solution package at the DIA Annual Meeting in Washington, D.C., today. Target e*CRF(TM) Version 3, an enhanced version of the company’s proven Target e*CRF application, will be available for general release on July 30, 2005. Target e*CRF provides pharmaceutical companies the ability to quickly and easily create, deploy, and manage web-based clinical trial applications by enabling cost-effective study design and online data capture and data management.
Ferring Pharmaceuticals A/S, a global, research-driven biopharmaceutical company, based in Copenhagen, Denmark, has entered into a 4-year agreement to license Target Health’s new Internet-based Clinical Trial Software. The agreement also includes cooperation with Target Health Inc. in the development of the new software. Ferring has been using Target Health’s current EDC software, Target e*CRF, for more than five years for programs resulting in two NDA approvals. There have also been two regulatory approvals in Europe and one in Canada.
“All global studies of Infacare are now solely EDC-based and we would never go back to paper,” said Benjamin Levinson, M.D., Vice President of Drug Development at Infacare Pharmaceutical Corporation, Plymouth Meeting, Pa., another user of Target Health’s EDC software. “Our new benchmark for locking a database, once all the information is available, is ONE DAY. We are extremely excited about the release of Version 3, which will further streamline our approach to clinical trial management, enhance our ability to file NDAs even faster, and maintain close control of the postmarketing environment.”
Target e*CRF Version 3 was developed in close partnership with one of Target Health’s premier clients, and is based on input from all areas of the clinical trial process, including trials management, data management, and biostatistics. Designed for users by users, the new system makes it possible for trial team members — even those without prior programming knowledge — to easily configure an entire eClinical trial. Target e*CRF Version 3 uses Microsoft platform technology and supports CDISC ODM standards to enable system flexibility and simplify integration with legacy systems.
Target e*CRF Version 3 simplifies the creation and execution of eClinical trials by providing a user-friendly software toolbox that includes:
— Target Studio(TM), a study creation tool that allows users to easily customize the application to meet the specific requirements of each clinical trial — all without prior knowledge of web programming languages and techniques. Target Studio automatically generates specification documents and test scripts for edit check configurations, and can be managed centrally to implement standardization.
— Target Console, a dashboard-style server management tool that provides a bird’s-eye view of the application to support system maintenance and facilitate the processing of clinical study data.
— Target Runtime Server, an integrated tool that facilitates the deployment, maintenance, execution, and retirement of Target e*CRF-configured applications and executes the application configuration files generated by Target Studio.
The first release of Target e*CRF has been used in clinical trials for more than five years. It currently boasts a successful track record of over 70 applications among 12 pharmaceutical companies, including 10 NDA and PMA programs, and programs resulting in 2 NDA and 1 PMA approvals.
About Target Health Inc.
Established in 1993, Target Health Inc. has been providing advanced clinical trial technology for more than a decade. As a full service CRO, the company is dedicated to all aspects of regulatory affairs, clinical research, biostatistics, data management, strategic planning, and drug device development. Its specialized advisors focus on the areas of toxicology, analytical methods validation, product and process development, quality assurance, and manufacturing. The company’s client list is comprised of some of the most highly respected pharmaceutical companies as well as smaller biotechnology firms. Target Health is based in New York.
For more information about Target Health and Target e*CRF, go to www.targethealth.com .
