• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

GlobalSubmit Signs Study Design Cooperative Research and Development Agreement (CRADA) With U.S. Food & Drug Administration

Posted on: Tuesday, 12 May 2009, 10:00 CDT

GlobalSubmit to Develop Software that Investigates the Use of the HL7 Format for Exchanging and Comparing Study Design Information

PHILADELPHIA, May 12 /PRNewswire/ -- GlobalSubmit Inc., a leading developer of software designed exclusively for the review and validation of electronic Common Technical Document (eCTD) global submissions, announces the signing of a Cooperative Research and Development Agreement (CRADA) with the U.S. Food & Drug Administration (FDA). The agreement states that GlobalSubmit will develop software that allows the FDA to view, analyze and compare study design information in a unified view. Presently, a significant number of study data submissions are paper-based, making the review process tedious and time-consuming. In addition, there is currently no consistent format for submitting study data, making it difficult for the FDA to perform critical evaluations such as cross-study reviews and safety analyses in the pre/post approval phases. To ameliorate this challenge, the FDA has commissioned GlobalSubmit to design and develop a commercial software application that allows FDA reviewers to more effectively review study design information and to compare that information with actual subject data.

Commenting on the significance of this new agreement, Jason Rock, Chief Technical Officer of GlobalSubmit, commented, "This is an important initiative for the FDA and sponsor organizations alike. The successful completion of this project will help the FDA to overcome a giant hurdle by enabling more efficient and accurate analysis of study information. We are pleased to be the FDA's preferred partner for this vital endeavor."

In addition to enabling study data comparison, the software developed as a result of this agreement will achieve several key objectives. It will:

• Allow the FDA to easily understand a study and to assess the impact of any protocol amendments
• Enable changing from SAS transport to Health Level 7 (HL7) Messages
• Establish clinical data warehousing in keeping with FDA's long term vision

While the FDA will recognize significant benefits by leveraging the development resources of GlobalSubmit, it is also sending a clear message that it may require electronic submissions in the near future. Sponsor organizations will benefit from the availability of the new software application developed under this agreement. The project will begin in late April, 2009 and is with an expected end date of October, 2011.

ABOUT GLOBALSUBMIT

GlobalSubmit is a products and services company that provides transparency in regulated healthcare products. The U.S. Food & Drug Administration and leading life sciences companies use our flagship applications, REVIEW(TM) and VALIDATE(TM), to review and validate electronic submissions. GlobalSubmit leads international efforts, comprising industry and government agencies, to standardize product and study information. The company is headquartered in Philadelphia, Pennsylvania.

SOURCE GlobalSubmit, Inc.

Source: PR Newswire

More News in this Category