Health Level Seven (HL7) Regulated Product Submissions (RPS)
Jason Rock, GlobalSubmit’s Chief Technology Officer, holds the chairman position of the Regulated Product Submissions group which is creating the next version of the eCTD standard. He has provided leadership and guidance to formalize a submission message standard for all regulated product submission to regulatory authorities. This message has been approved as a draft standard and has participation from governments, industry, vendors and educators. Through leadership and diplomacy, Mr. Rock has successfully brokered a number of agreements and consensus on various topics within the group.
CDISC SDTM Message Development
Jason leads the development of the CDISC SDTM Message Development within HL7. This message will incorporate existing standards created in Clinical Data Interchange Standards Consortium (CDISC) which has formed a formal relationship with HL7. The new standard will incorporate the Study Data Tabulation Model (SDTM) created at CDISC and incorporate and harmonise it with the larger HL7 standards. Building on his success from leading the RPS standard, Jason will lead the development of the implementation guide for the approved version of the message.
Study Design Software CRADA
GlobalSubmit Inc. has entered into a Cooperative Research and Development Agreement (CRADA) with the U.S. Food & Drug Administration (FDA) to develop software to allow 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.
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