Informed Consent Management Platform

The complete platform
for informed consent.

Enterprise-grade informed consent that works alongside your existing EDC, CTMS, and EHR.

Build, review, approve and collect compliant informed consent in minutes, not months. No implementation project. No professional services. Just a platform that works.

HIPAA Compliant
FHIR R4
21 CFR Part 11
ESIGN Act
eIDAS

No credit card required. Clinical and research plans available.

Informed Consent Lifecycle
Draft and Author
IRB Review
Clinical Audit
Participant Dispatch
Teach-Back
Signature
FHIR Export
Audit Archive
Every event cryptographically hashed and timestamped at the moment it occurs.
Built for compliance withHIPAAHL7 FHIR R4ESIGN ActeIDASUETA21 CFR Part 11GDPR
§ 01 · LIFECYCLE

Every informed consent follows the same lifecycle.

ConsentCollect manages every stage, from first draft to sealed audit record. No handoffs. No gaps. No improvising.

Author
Build or import your form. AI checks it before anyone sees it.
Review
IRB and clinical teams comment inline. Every revision logged.
Approve
Published once approved. All changes locked to the audit record.
Understand
Participants complete education and teach-back assessments.
Sign
Sequential, enforced signing with biometric chain of custody.
Audit
Every action cryptographically hashed and timestamped.
Export
FHIR R4 write-back to your EHR, EDC, or CTMS automatically.
§ 02 · SEE IT IN ACTION

Consent Form Builder

Create compliance-ready forms quickly with our visual drag-and-drop designer, inline signature placement, active clinical auditor checks, and the ability to send drafts for review to get inline comments.

Visual Drag-and-Drop Layouts
Interactive Signatures and Initials
Active Clinical Auditor Checks
Send Draft for Peer Comments
Consent Form Builder
CLARA Clinical Auditor
Active Form Draft
Cholecystectomy Consent v2.4
Reading LevelGrade 13.2
⚠ Too complex for informed consent
2 issues detected. Readability above Grade 8 threshold.
§ 03 · DOCUMENT INTELLIGENCE

Most platforms collect consent. We help you improve it.

Before any form reaches a participant, ConsentCollect checks it for readability, missing clauses, and compliance gaps. Automatically. Then it helps you fix them.

  • Readability audit on every saveFlesch-Kincaid and SMOG grading. Flags forms above Grade 8.
  • Missing clause detectionChecks for required disclosures, alternatives, and risk statements.
  • Clara AI rewriteSimplifies language to patient-accessible reading levels in one click.
  • IRB comment resolutionClara reads IRB comments and proposes targeted fixes directly in the form.
  • Automatic version historyEvery revision is audit-logged. Rollback is instant.
§ 04 · HEALTHCARE APPS CONNECTIVITY

Connect eConsent to 400+ healthcare apps instantly.

ConsentCollect natively integrates with Keragon, the leading medical-grade automation engine. Clinical coordinators and sponsors can build seamless, HIPAA-compliant integrations between eConsent forms and EMRs, databases, AI transcription tools, and communication suites—with zero custom code.

  • EHR Intake WorkflowsSync patient booking in AthenaHealth, Healthie, or Dentalink to automatically dispatch custom procedure consent forms.
  • AI Note Triggered ConsentFinish note dictation in Heidi or Vertex AI, triggering custom consent creations dynamically.
  • Tamper-Proof Audit BackupLog final transaction metadata in Microsoft Excel and push cryptographic forensic audit files directly to Dropbox.
  • Real-time CRM & Support SyncTrack signature progression or consent withdrawals automatically in HubSpot and open tickets in ZenDesk.
Keragon Integration Engine
ConsentCollect Logo
EHRAthenaHealth
Update Chart status
§ 05 · WHAT IT SOLVES

Every step of the informed consent lifecycle, handled.

Comprehension

Participants who can prove they understood, before they sign.

Teach-Back quiz and enforced video review with millisecond-level engagement tracking. The signature field stays locked until comprehension is verified.

Chain of Custody

A signing sequence no party can break or reverse.

Subject, guardian, interpreter, witness, investigator. Each link depends on the last. Sequence violations are structurally impossible, not just discouraged.

Digitization

Legacy paper forms digitized without touching patient data.

Drop a PDF or photograph a handwritten form. PHI Shield keeps patient identifiers out of the AI pipeline entirely. The output is a structured, audit-ready digital consent.

Explore capabilities
Research Scale

One link enrolls an entire trial cohort without coordinator overhead.

CSV manifest upload with Double-Lock identity verification. Participants self-enroll. Investigators track status in real time. Coordinators stop chasing signatures.

Audit Trail

Evidence that holds up in discovery, not just internal review.

Every event, IP address, device, geolocation, timestamp, biometric seal, is cryptographically hashed at the moment it occurs. The record cannot be altered retroactively.

Deadline Management

No procedure canceled for a form that sat in someone's inbox.

Automated SMS and email reminders. Expiry alerts that fire before deadlines, not after. Deadline extension and re-invitation in one click.

EHR and EDC Integration

Universal integration, self-serve. 300+ connections via Keragon.

Write back signed consents automatically to your EHR (Epic, Cerner) or clinical trial database (REDCap, Veeva, Medidata). Secure system-to-system sync. BYO-API or Keragon.

IRB Workflow

IRB revision cycles resolved in minutes, not revision rounds.

Clara AI reads IRB comments and proposes targeted corrections. Apply them directly to your ICF. Version history is automatic. Every revision is audit-logged.

Explore capabilities
Geofencing

Restricted signing boundaries and verified site location.

Ensure trial protocol compliance by enforcing or flagging signatures completed outside authorized clinical boundaries, backed by tamper-resistant location telemetry.

Clinical Auditor and Liability Shield

An invalid consent form is a $425,000 liability.

Consent forms are routinely thrown out in court because they are written at a college grade level, omit critical alternative treatments, or lack chronological proof. Paper forms and standard e-signatures leave you defenseless in front of a jury.

$425k+
Average national settlement payout for medical malpractice claims.
$580k
Annual loss per hospital from misplaced or delayed paper consent forms.
66%
Of surgical procedures missing consent forms on the morning of surgery.
$62/min
Cost of operating room delays from preventable consent paperwork gaps.
CLARA CLINICAL AUDITOR
2 ISSUES DETECTED
ACTIVE DOCUMENT DRAFT
Cholecystectomy_Informed_Consent_v4.pdf
Critical Readability DeficitBLOCKER

Form scored 12.4 on Flesch-Kincaid (University-level reading). Malpractice courts throw out documents exceeding Grade 8.0.

Missing Alternate Treatments DisclosureWARNING

No reference to non-surgical biliary management discovered. Omission of medical alternatives triggers 78% of disclosure lawsuits.

Bypass Protection Enabled: If you publish without auditing, ConsentCollect logs a permanent, non-repudiable AUDIT_BYPASSED affidavit to your record.
§ 06 · WHY TEAMS SWITCH

We don't replace your existing systems.
We replace the gaps between them.

Your EDC captures data. Your EHR stores records. Your CTMS tracks studies. None of them were built to manage the informed consent lifecycle.

Signature tools stop at the signature.

They do not verify participant comprehension, enforce multi-party signing sequences, or produce forensic audit evidence. A signature is not the same as informed consent.

Data capture platforms are not consent platforms.

They track records. They were not designed to guide a participant through education, comprehension verification, and sequenced signing. That gap is where compliance risk lives.

Enterprise consent modules require enterprise timelines.

Six to twelve weeks of implementation, professional services fees, and procurement cycles, for a consent workflow your team needed last quarter. ConsentCollect is running in minutes.

ConsentCollect is purpose-built for the informed consent lifecycle. It connects to your existing stack and handles the workflow that none of your current tools were designed for.

§ 07 · THE DIFFERENCE

Same outcome. A fraction of the time.

Every capability enterprise platforms offer for consent. None of the overhead.

Feature
Traditional Workflow6 to 12 weeks to deploy
ConsentCollectRunning in minutes
Form authoring and templates
IRB review and commenting
Email threads
Inline, version-tracked
Readability and compliance audit
Participant education and teach-back
Sequential, enforced signing
Forensic audit trail
PDFs in a folder
Cryptographic, immutable
EHR and EDC integration
Manual export
Automated FHIR
Time to deploy
6 to 12 weeks
Minutes

Same capability. None of the overhead.

§ 08 · FOR RESEARCH TEAMS

Run a 500-participant trial. Enroll them all from one link.

Research consent has different anatomy: multiple parties, sequential authority, regulatory traceability, and enrollment at a scale that individual form management can't touch.

Complex consent chains, fully supported.

Subject, LAR, guardian, minor assent, interpreter, witness, investigator. Each role has a defined position in the signing sequence. The system enforces it.

Participants must be on-site to sign.

GPS geofencing locks the signing link to a defined radius around the trial site. Remote signing from outside the boundary is blocked and logged.

Biospecimen and sub-study opt-ins built in.

Modular consent blocks for genetics, biobanking, and secondary research. Participants opt into exactly what they choose. Each decision is recorded separately.

NCT numbers bound at the ICF level.

Trial registry numbers are embedded in the form metadata. No manual typing, no coordinator errors, no ICF that references the wrong study.

Double-Lock Identity Verification
OTP (Lock 1) plus personal access code from study letter (Lock 2). Both required before enrollment proceeds.
Real-Time Enrollment Dashboard
Live status for every participant: pending, awaiting investigator, fully signed. Action alerts fire before deadlines are missed.
Lazy Enrollment — One Link, Many Participants
The master link is published once. Each participant self-identifies against the manifest and receives a unique consent instance.
Full Forensic Chain Per Participant
Every enrollment clone carries its own cryptographic snapshot hash, audit trail, and FHIR export. Each record is independent.
§ 09 · COMPLIANCE ARCHITECTURE

Compliance isn't a feature. It's the foundation.

Built zero-trust, privacy-first, from the architecture up. Not retrofitted onto a generic document tool.

  • AES-256 encryption for all PHI at rest and in transit
  • Cryptographic document snapshot hash generated at send-time. Tamper detection built in.
  • IP address, device fingerprint, and GPS coordinates logged per signature event
  • Biometric attestation (FaceID, Fingerprint, PIN) required at final signing step
  • Immutable audit logs structured for litigation discovery and IRB submissions
  • Role-based access controls with full session audit for every staff action
HIPAA
Fully HIPAA Compliant PHI handling and data governance
ESIGN
Electronic Signatures in Global and National Commerce Act
FHIR R4
HL7 Fast Healthcare Interoperability Resources — validated export
eIDAS
EU Electronic Identification and Trust Services
UETA
Uniform Electronic Transactions Act
21 CFR 11
FDA Electronic Records and Signatures regulations
§ 10 · PRICING

Per active patient. Not per envelope.

You pay for the patients you actively manage. Your entire workflow, not your click count.

Free Sandbox
$0/forever

Try all features risk-free with 1 active form and a cap of 5 signers total. No credit card required.

Start Free
Clinical Practice
$49/mo

Solo practitioners through multi-physician clinics. Staff seat-based tiers from $49 to $399/mo.

View Clinical Plans
Research and Clinical Trials
$149/mo

Independent PIs through large CRO networks. Per-study pricing with unlimited participants and signatories.

View Research Plans

Large clinic networks, hospital systems, and multi-site CROs — contact Hospital Relations

Paid upgrades have no free trials. Refunds are strictly limited to a 3-day window for unused accounts. Read our Refund Policy.

§ 11 · QUESTIONS

The questions your legal team will ask.

Clinical and Research Plans

Ready to modernize informed consent?

Build, review and collect informed consent in minutes, not months.

No credit card required. Clinical and research plans available.