Integrated Evidence & Submission Engineering
Scale from one study to a reviewable application
Plan and deliver pooled safety/efficacy data, integrated analyses and a technically conformant multi-study submission.
Final study packages, portfolio standards, integration SAP and submission plan
Validated integrated data/analysis package and regulator-ready application evidence
Real course content
5 chapters
Each chapter contains instructional sections, a CLIN-301 worked workflow, failure modes, a concrete deliverable, and an assessment.
The eCTD structure
The five CTD modules, where data and analysis live (M5), lifecycle and sequences, regional differences.
Chapter 1 of 5
The submission data package
SDTM + ADaM + define.xml, the reviewer’s guides, analysis programs, and the standardization plan.
Chapter 2 of 5
Conformance & agency expectations
The Technical Conformance Guide, Standards Catalog, Pinnacle 21 for submission, common findings.
Chapter 3 of 5
Communicating standards & data with agencies
The standardization plan, pre-submission meetings, information requests, reproducing an analysis on request.
Chapter 4 of 5
Putting it together — a submission dry run
Package assembly checklist, end-to-end traceability, validation gates, what reviewers open first.
Chapter 5 of 5