Electronic informed consent
Fully digital consent workflows where participants review, understand, and sign remotely on any device. From initial consent through to re-consent, every step is tracked, versioned, and audit-ready.
Digital consent capture with e-signatures, video calling, and full audit trails.
Build participant information sheets with rich content, images, diagrams, and version control.
Conditional eligibility screening to qualify participants before consent.
Participant identity verification with photo ID capture and matching for regulatory compliance.
Verified identities, flexible delivery, and full version control on every consent document.
KYC identity verification to confirm participant identity before consent. Two-factor authentication for logins bridged to verified phone numbers and email addresses for added security.
Gather consent in person at a study centre or entirely remotely with equal compliance and security. Both pathways produce the same audit-ready, timestamped e-signature records.
Multiple consent forms per study, each fully versioned with automatic lockout. When a document is updated, participants are prompted to re-consent before they can continue in the study.
Enterprise-grade encryption, UK/EU data residency, and full compliance with GDPR, HIPAA, and 21 CFR Part 11. Cyber Essentials Plus certified.
Built-in video calling for remote consent appointments. Coordinators can walk participants through the consent form face-to-face, answer questions in real time, and capture signatures during the call.
When consent documents are updated, participants are automatically prompted to review changes and re-consent. Every version is retained with a complete change history.
Built-in identity verification confirms participant identity before consent is captured. Supports knowledge-based authentication and two-factor verification.
Every action is logged with timestamps, user identity, and IP address. Inspection-ready from the moment your study goes live.
Every layer of Trialflare eConsent is designed to protect your data, your participants, and your study's regulatory standing.
Full regulatory compliance with data stored in UK/EU centres.
Electronic signatures and validated systems for FDA submissions.
Workflows structured around Good Clinical Practice guidelines.
Independently verified cyber security controls and infrastructure.
Create consent forms with embedded images, diagrams, and comprehension checks. Participants engage with the material at their own pace, ensuring genuinely informed consent.
Embed explanatory images and rich content directly into your consent forms. Participants can review complex information in the format that works best for them.
When a consent document is updated, affected participants are automatically notified and guided through a streamlined re-consent process. No manual tracking required.
Built-in comprehension questions confirm that participants understand key study information before signing. Supports regulatory requirements for truly informed consent.
Digital consent capture with e-signatures, video calling, and full audit trails.
Build participant information sheets with rich content, images, diagrams, and version control.
Conditional eligibility screening with branching logic to qualify participants before consent.
Participant identity verification with photo ID capture and matching for regulatory compliance.
Built-in video calling for remote consent appointments. Participants and coordinators can connect from anywhere while signatures are captured in real time.
Consent documents sync directly with your eTMF and document management systems. Signed forms are archived automatically with full version history and metadata.
Connect with third-party identity verification services to confirm participant identity before consent is captured. Supports knowledge-based and document-based verification.
Consent does not happen in isolation. Trialflare connects your consent workflows with the tools and systems your team already uses, so nothing falls through the cracks.
GDPR, HIPAA, 21 CFR Part 11, ICH GCP, and Cyber Essentials Plus certified. UK/EU data centres, 2FA, role-based access, and full audit trails on every action.
From building your consent form to tracking versions and re-consent, Trialflare handles the complexity so your team can focus on the research.
Build consent forms quickly with templates, image embedding, and comprehension checks ready to deploy from day one.
Images, diagrams, and comprehension checks ensure participants genuinely understand what they are consenting to.
Eliminating paper-based consent processes and site visits reduces overhead and accelerates enrolment timelines.
Every consent action is timestamped and logged, giving you a complete audit trail for regulatory submissions and inspections.
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Create consent documents using a straightforward form builder. Add sections, embed images and diagrams, and configure comprehension questions.
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Embed explanatory images so participants engage with the information that is relevant to them.
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Participants receive a secure link, review the consent material at their own pace, complete comprehension checks, and provide their e-signature.
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Monitor consent status across all participants from a single dashboard. When documents are updated, automatic re-consent workflows keep everything current.
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