What is ConsentCollect?
ConsentCollect is a secure, clinical-grade patient electronic consent (eConsent) and documentation platform designed for healthcare organizations, biotechnology sponsors, and contract research organizations (CROs). The platform turns traditional, paper-based consent processes into high-integrity clinical data assets by digitizing forms, enforcing sequential signing orders, and maintaining unalterable audit trails. It is built to meet strict regulatory standards, including FDA 21 CFR Part 11 electronic records requirements, HIPAA data privacy controls, and GDPR rules.
By using a web-native form builder instead of static PDFs, ConsentCollect ensures that signer flows are responsive and easy to complete on smartphones and tablets. The platform includes advanced comprehension tools, such as teach-back quizzes, read-aloud accessibility options, and video integration, to help participants understand study protocols and treatment risks. Furthermore, ConsentCollect protects research safety by incorporating automated follow-up reminder loops, clear consent withdrawal pathways, compliance check linters, and a minimum seven-day export guarantee so you are never locked out of your compliance data.
To eliminate manual data entry and silos, ConsentCollect features a zero-cost, self-serve integrations engine. Paid workspace subscribers can configure direct system-to-system write-backs to Electronic Medical Records (EHRs like Epic and Cerner) or study databases (EDCs like REDCap, Veeva Vault, and Medidata Rave) using their own developer credentials. Signed consent PDFs and completed metadata write back automatically upon signature completion.