ConsentForge

ConsentForge is a web app (tablet-friendly) that helps clinical trial sites and sponsors prevent informed-consent mistakes that trigger deviations, re-consents, and audit findings. It provides version-controlled eConsent packets, country/IRB-specific checklists, and a step-by-step “consent run” workflow that flags missing signatures, wrong dates, outdated ICF versions, and required ancillary forms before the visit is closed. An AI layer (optional) reads uploaded signed PDFs and highlights likely issues (e.g., initials missing on page 7, date format mismatch, witness required but absent) and generates a clean query list for coordinators. It also maintains an audit trail, tracks re-consent triggers by protocol amendment, and exports evidence packages for monitors. This is not a full EDC replacement; it focuses narrowly on the highest-frequency, most expensive documentation failure point: consent quality and completeness.