Methodmade offers video‑driven documentation tools that help pharmaceutical companies capture detailed standard operating procedures during tech transfers, reducing the typical 6‑12 month runway and minimizing missing critical details. By streamlining CDMO onboarding, the platform accelerates Phase 2 trial readiness and cuts operational burn for biotech firms.
Funding
Funding not disclosed
Founders
Product
Problem
Contract development and manufacturing organizations (CDMOs) often rely on written standard operating procedures (SOPs) that omit critical details during tech transfers, leading to prolonged onboarding cycles of 6‑12 months and delayed Phase 2 trial readiness.
Solution
Methodmade offers a video‑driven documentation platform that captures SOP execution in high‑resolution video and applies deterministic AI to generate compliant manufacturing procedures and batch records automatically. The system links operator observations directly to master batch records, creating a rapid feedback loop that aligns on‑floor execution with the author’s intent. All documents are stored on a Merkle‑based cryptographic ledger that self‑audits each access, providing zero‑trust verification and immutable audit trails. Deployment runs within the customer’s Azure tenant in under two hours, leveraging existing Microsoft Entra credentials and eliminating the need for separate security audits. The platform includes a pre‑executed QMS suite and a low‑effort validation kit, allowing users to certify compliance with a single user‑acceptance test before commercial manufacturing begins.
Target Audience
Primary customers are CDMOs, pharmaceutical manufacturers, and contract research organizations that need fast, compliant onboarding of manufacturing procedures for Phase 2 trial preparation.
Features
- AI‑drafted, human‑signed SOPs generated from subject‑matter‑expert video recordings, reducing tech‑transfer time from months to minutes
- Video‑anchored master batch records that deliver frame‑by‑frame visual instructions to operators, minimizing execution deviations
- Blameless operator observation capture that feeds real‑time deviations back into SOPs for rapid iteration
- Merkle‑based cryptographic WORM ledger for immutable document integrity and instant forensic recovery
- Azure‑native deployment with zero‑trust verification, using existing enterprise credentials and no additional accounts
- Pre‑loaded QMS package with validated video batch records and a Lego‑based validation kit for low‑risk user acceptance testing
- Interactive navigation of documentation with step‑specific video segments for remote verification and troubleshooting