CMC sections drafted from the quality records you already keep. In development with design partners.

Compose Clinical Study Reports from your linked source data — AE listings, datasets, protocols — and generate the safety narrative appendix straight from the same source graph. One review workflow, one evidence pack, one traceable story from listing to submission.

Draft CTD Module 2.5 Clinical Overviews and Module 2.7 Clinical Summaries from your clinical study reports and integrated analyses. Each section carries the ICH M4E(R2) text it must satisfy, every sentence cites the study report passage or table behind it, and the benefit-risk conclusions stay with your writers.

Upload an existing CSR, a vendor validation protocol, an SOP or a guideline and TraceDraft analyses it against the structure it should follow: a section-by-section summary, what each required section covers, what is missing, and where the text disagrees with itself. Every finding cites the uploaded document.

A standard safety narrative template — Patient Identification, AE Description, Medical History, Study Drug, Clinical Course, Causality and Narrative Summary — with each section wired to the source types it needs. The final narrative slots directly into the CSR appendix.

Project-scoped source management ingests the messy inputs — AE listings, datasets, protocols, PDFs — and turns them into the citable atoms behind every generated section. Writers see source coverage before they draft, so gaps are addressed early, not at QC.

A dedicated review queue routes generated sections to human reviewers with the source-link count in view — so reviewers validate AI output against the actual data behind it. The section status workflow keeps everyone honest about where a draft actually is.