Innovation

We Pride Ourselves on Ingenuity and Advancement

Innovation Moves the eCTD Industry Forward

GlobalSubmit’s mission is to facilitate the approval of regulated healthcare products through technology innovations.

GlobalSubmit’s key creative initiatives include:

Health Level Seven (HL7) Regulated Product Submissions (RPS)

Jason Rock, GlobalSubmit’s Chief Technology Officer, previously served as the chair 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 submissions to regulatory authorities. RPS 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

Mr. Rock 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 harmonize 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.