Comment from ZS Associates Inc.
AnonymousSupportBusiness
Summary: ZS Associates Inc., a management consulting and technology firm, supports the FDA's proposed pilot program to assess AI-enabled technologies in early-phase clinical trials. They argue that the pilot will improve efficiency, speed, and decision-making quality by helping sponsors and the FDA stress-test critical assumptions and mitigate risks of late-stage regulatory failures.
Comments from ZS Associates Inc.
ZS appreciates the opportunity to respond to the FDA's Request for Information on the proposed pilot to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early-phase clinical trials. We are excited about the potential of AI in clinical trials from study design to planning, monitoring, analysis and submission.