Consent Management for Clinical Trials – LP
Certinal replaces paper ICFs, wet-ink signatures, and disconnected site workflows with one platform for clinical trials. Every consent captured, signed, version-controlled, and filed to your eTMF
Consent Management for every clinical trial
Certinal replaces paper ICFs, wet-ink signatures, and disconnected site workflows with one platform for clinical trials. Every consent captured, signed, version-controlled, and filed to your eTMF
- HIPAA
- 21 CFR Part 11
- ICH E6 (R3)
- FDA eConsent
- 45 CFR Part 46
- SOC 2 Type II
Trusted by healthcare organizations
"Certinal's Healthcare Consent & Compliance Platform has transformed our digital consent workflows through seamless EMR integration. It’s a vital step in our commitment to delivering secure, innovative, and patient-centric care." Henrik Andersson CEO, Chief Innovation & Technology Officer of Bumrungrad International Hospital
Compliance is the starting line
05
HIPAA
Protected health information encrypted at rest and in transit. Audit trail on every consent event. BAA available.
01
21 CFR Part 11
FDA-mandated electronic signature standards. Signer authentication and tamper-evident audit trails on every consent event.
02
ICH E6 (R3) GCP
Updated Good Clinical Practice guidelines requiring risk-based monitoring and electronic source data. Certinal meets these natively.
03
FDA eConsent Guidance
FDA framework for electronic informed consent in clinical investigations. Multimedia delivery and comprehension checks supported.
04
45 CFR Part 46
Federal protections for human research subjects. Documented informed consent with required elements and IRB-approved templates.
06
SOC 2 Type II
Independently audited controls over how Certinal stores, processes, and transmits participant data.
The consent problem in clinical trials isn't one problem. It's three.
Consent slows enrollment. Enrollment pressure cuts corners on quality. Cut corners surface at inspection. Each problem feeds the next.
Certinal breaks the cycle at every stage
eConsent workflows, comprehension checks, real-time site visibility, audit automation, and inspection-ready evidence — one platform that fixes speed without sacrificing compliance.
Consent is the enrollment bottleneck
Scheduling visits, printing ICFs, waiting for signatures. Screen failures burn effort on participants who never randomize. Hybrid and decentralized designs need remote consent — but sites still run paper.
- Consent scheduling adds 7–14 days to enrollment per participant
- Screen failure rates mean a third of consent effort produces no data
- Sites without eConsent can't activate decentralized trial arms
Speed pressure erodes consent quality
Sites rush consent to hit activation targets. No comprehension checks. No record of what was reviewed before signing. Vulnerable populations get a one-size-fits-all process.
- No proof participants understood protocol risks before signing
- Non-English speakers and elderly participants face compounding barriers
- Sponsors can't see quality across sites until a monitor visits
The shortcuts compound into inspection exposure
Consent is the most common FDA 483 observation category. Unstandardized processes, missing audit trails, and documents that fail 21 CFR Part 11. Remediation after a finding is retrospective and expensive.
- 483 consent findings can trigger clinical holds and delay approvals
- Retroactive remediation costs 10× what built-in compliance would have
- No consolidated trail connecting consent, comprehension, and signature
eConsent — captured, signed, governed, and proven
Informed consent, protocol-specific authorization, re-consent — captured, signed, and filed to the trial master file before anyone asks where it is. Every event audit-trailed. Every document inspection-ready.
eConsent workflows for clinical trials
Protocol-specific informed consent from Phase I through Phase IV. Launches inside your CTMS or EDC. Study-specific ICFs auto-matched to the visit schedule. Consent status visible in real time.
Remote & decentralized
Participants consent from any device. Multimedia explanations, comprehension checks, and e-signatures in one flow. Built for decentralized trials.
Electronic Signatures
Legally binding, tamper-evident, time-stamped. Signer identity verified at capture. Full chain-of-custody from signature to storage. 21 CFR Part 11 compliant.
Protocol amendment management
Version-controlled ICF repository linked to amendments. Outdated versions auto-retired. Re-consent tracked per participant. IRB status visible at every site.
Frequently Asked Questions
What types of clinical trial consent does Certinal handle?
Does Certinal integrate with clinical trial management systems?
How does Certinal meet 21 CFR Part 11 requirements for clinical trials?
Can participants complete eConsent before their site visit?
Does Certinal support decentralized clinical trials?
How does Certinal handle protocol amendments and re-consent?
How long does implementation take for a clinical trial sponsor?
Protocol-specific informed consent, re-consent after amendments, assent for pediatric participants, legally authorized representative consent, and emergency use authorization. Documents are version-controlled, linked to specific protocols, and audit-trailed to the trial master file.
Directly with major CTMS and EDC platforms including Medidata Rave, Veeva Vault, and Oracle Clinical. eConsent forms launch inside your trial system and signed documents write back to the eTMF.
Signer authentication, tamper-evident seals, and complete audit trails on every consent event. Covers informed consent, IRB documentation, and all FDA-regulated electronic records generated during the trial.
Yes. Participants receive a secure link via SMS or email. Multimedia study information, comprehension assessments, and e-signatures completed remotely. Signed consent is in the eTMF before the visit.
Yes. Remote eConsent from any device with identity verification, multimedia delivery, and comprehension checks. Participants consent on their own schedule. Every interaction audit-trailed and inspection-ready.
Amendment-triggered re-consent workflows notify participants and sites automatically. Consent version linked to protocol version. Dashboard tracks re-consent completion per participant, per site.
10 business days for a single study. Multi-study rollouts within 30–60 days. Dedicated implementation manager on every deployment.
Every clinical trial starts with informed consent. Every consent needs proof.
Certinal gives you both. One platform. See it in 15 minutes.
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