Streamlining Clinical Data Flow from Study Design to Submission: Leveraging ICH M11 and Clinical Data Standards

Session details:

ICH M11 introduces a structured protocol framework with the potential to transform how clinical data flows from study design through execution and regulatory submission. The speakers cover:

• How ICH M11 can enable earlier alignment between protocol design, study build, and downstream data standards

• The role of clinical data standards in improving traceability from protocol to submission

• Opportunities to reduce manual rework and accelerate timelines through structured, reusable protocol content

• Lessons learned and challenges in operationalizing structured protocols across teams and systems