AI-Native Life Sciences Authoring & Regulatory Platform
One GxP-compliant platform. Five writing pillars. 25+ regulatory frameworks. Up to 91% cost reduction vs. traditional agencies.
ClinWrite automates complex life sciences documentation—from initial clinical study reports to multi-authority eCTD publishing—with strict human-in-the-loop review and immutable audit trails.
Key Capabilities Across 5 Pillars
- Pillar A — Clinical Writing
- Pillar B — Scientific Writing
- Pillar C — Medical Communications
- Pillar D — Regulatory & eCTD Publishing
- Pillar E — Trial Transparency & Disclosure
Pillar A — Clinical Writing
- Draft ICH E3-compliant CSRs, Investigator Brochures, and DSURs in days. Includes MedDRA coding, TLF linking, and direct one-click filing to Veeva Vault eTMF.
- Parallel Cross-Functional Review: Facilitates concurrent reviews across biostatistics, pharmacovigilance, QA, and regulatory affairs with tracked comments and integrated voice-note audio transcription.
Pillar B — Scientific Writing
- Transform clinical trial data into journal-ready manuscripts, abstracts, and posters. Built-in verification for ICMJE authorship, CONSORT checklists, and direct submission connectors.
- Automated Pre-Submission Gateways: Verifies Vivli de-identified data-sharing statements, GPP 2022 open-access rules, ethics approvals, and direct submission readiness via ScholarOne connectors.
Pillar C — Medical Communications
- Generate substantiated HCP slide decks and patient literature. Enforces a mandatory MLR compliance gate, Flesch-Kincaid $\le$ Grade 8 readability, and NABH 6th Edition evidence tracking.
- Built-in DPDPA 2023 Privacy Checks: Automatically scans and validates all communication collateral to ensure complete patient data de-identification and total data privacy compliance.
Pillar D — Regulatory & eCTD Publishing
- Compile and validate CTD Modules 1–5 for simultaneous global submissions. Fully compliant with FDA eCTD v3.2.2 and mandatory PMDA eCTD v4.0 standards.
- Live Health Authority Response Tracker: Tracks agency feedback, manages Day 74/80 review countdowns, and uses AI drafting to keep query responses ahead of strict deadlines.
Pillar E — Trial Transparency & Disclosure
- Automate EU CTR Article 37 layperson summaries, CTIS filings, and plain-language conversion with permanent redaction audit logs.
- HEOR & Global Value Dossiers (GVD): Generates health economics and outcome research dossiers pre-structured for payer assessment bodies including NICE, HAS, and G-BA.
Traditional Agency vs. ClinWrite
| Deliverable | Agency Cost | ClinWrite | Efficiency Gain |
|---|---|---|---|
| Phase 3 CSR | $140,000 | $6,000 | $134,000 saved (vs. 16 weeks) |
| CTD Module 2.7 | $130,000 | $9,500 | $120,500 saved |
| eCTD Compilation | $50,000 | $4,500 | $45,500 saved |
| Scientific Manuscript | $25,000–$60,000 | $1,500–$3,000 | ~90% cost reduction |
Built for Regulated Environments
Full GxP Compliance: Aligned with 21 CFR Part 11, EU Annex 11, ALCOA+, and GAMP 5.
Cryptographic Traceability: Every version, edit, and approval secured via SHA-256 electronic signatures and WORM-compliant audit logs.
Zero Model Hallucinations: AI drafts are strictly anchored to source trial data with visible confidence scores and mandatory reviewer approval.