Drug Evaluation Committee Current Status and Potential of Digital Transformation (DX) in Clinical Development
Clinical Evaluation Subcommittee
May 2024
Recently, "DX" has become a hot topic in all business fields and industries. In discussing DX, we often focus on the innovativeness of digital technology, but it is important to determine "what and how" we want to change our existing operations and processes through digital means. We believe that it is important to determine "what and how we want to change" our operations and processes through digital means.
In Task Force 1 of the Clinical Evaluation Subcommittee 2023, we focused on various processes in clinical development (planning, enrollment of trial participants, obtaining consent, submitting for approval, etc.). First, we investigated what kind of DX (and pre-digitalization) initiatives are being undertaken. We have compiled as broad and specific a list of actual cases as possible to serve as a basis for future discussions and deliberations.
Japan Pharmaceutical Manufacturers Association
Pharmaceutical Evaluation Committee, Clinical Evaluation Subcommittee
Task Force 1 for FY 2023
Current Status and Potential of Digital Transformation (DX) in Clinical Development
Deliverables of the Drug Evaluation Committee Return to list of all deliverables