TrialScribe turns your clinical data into compliant IND, NDA, and eCTD document sections. Stop spending months on manual authoring. Start submitting faster.
Every pharma and biotech company uses some form of eCTD publishing software. But the actual work of gathering clinical data, structuring it into CTD sections, and writing compliant narratives? That's still done by hand.
Regulatory writers spend weeks producing Module 2 summaries, nonclinical overviews, and clinical study reports. TrialScribe compresses that timeline from months to minutes.
TrialScribe understands CTD structure, regulatory requirements, and the language health authorities expect.
Upload clinical study data and TrialScribe generates CTD-compliant document sections. Module 2 summaries, nonclinical overviews, clinical pharmacology sections.
Pulls structured data from clinical databases, study reports, and source documents. No more copy-pasting between systems to assemble your submission.
Every generated section follows ICH guidelines, FDA/EMA formatting requirements, and eCTD v4.0 structure. Compliance is the default, not an afterthought.
Built for the new global standard. As FDA, EMA, and PMDA mandate eCTD v4.0 through 2026, TrialScribe outputs documents in the right format from day one.
Medical writers, regulatory affairs, and clinical teams review and refine drafts together. Track changes, leave comments, iterate until submission-ready.
Generate region-specific Module 1 content for FDA, EMA, PMDA, Health Canada, and emerging markets. One dataset, multiple jurisdictions.
From data to submission in four steps.
Upload study reports, CSRs, nonclinical data, and manufacturing information. TrialScribe ingests and structures everything.
IND, NDA, BLA, ANDA, or supplement. Choose the target agency and TrialScribe configures the CTD module structure automatically.
TrialScribe drafts each document section using your data and regulatory guidelines. Your team reviews, edits, and approves.
Download eCTD-compliant PDFs, XMLs, and metadata files ready for publishing through your existing submission gateway.
Every week a submission is delayed, patients wait longer for treatments that could help them. TrialScribe exists to make that wait shorter.