Frequently Asked Questions
Everything you need to know about how Clear Trials works, our compliance approach, and what to expect.
Product
What does Clear Trials actually do?
Clear Trials transforms complex clinical trial documents — informed consent forms (ICFs), protocols, and study guides — into plain-language summaries at a 6th–8th grade reading level. Participants and their caregivers get 24/7 access to these simplified materials, a visual timeline, a Q&A tool sourced from their actual documents, and study contact information.
Is this the same as eConsent?
No. eConsent digitizes the signing process. Clear Trials picks up where consent ends — we make the content understandable and accessible throughout the entire trial, not just at enrollment. We complement eConsent platforms, not replace them.
Is this a chatbot?
No. Clear Trials uses AI to transform and index your documents, but the participant-facing Q&A tool retrieves relevant passages from the actual trial documents with source attribution. It does not generate open-ended responses. Every AI-generated summary is reviewable and editable by your team before participants see it.
What documents does Clear Trials work with?
We accept informed consent forms, protocols, study guides, and other participant-facing materials. Upload PDFs, Word documents, or integrate directly with your document management system.
How long does implementation take?
Most implementations are live in weeks, not quarters. You upload your documents, review the AI-generated summaries, and distribute access codes to participants. No complex IT integration is required for the standard implementation.
Compliance & Security
Does this require IRB approval?
Clear Trials simplifies and presents your existing IRB-approved materials — it does not modify the original documents or create new medical content. Our AI guardrails are designed in consultation with IRB professionals to ensure outputs stay within appropriate boundaries. We recommend consulting your IRB, and we provide documentation to support that process.
Is Clear Trials HIPAA compliant?
Yes. Our infrastructure is built on AWS with HIPAA-compliant architecture. No Protected Health Information (PHI) is stored in the application database. We execute Business Associate Agreements (BAAs) with all applicable partners.
What about ICH-GCP compliance?
Clear Trials is designed to support ICH-GCP compliance. Every document transformation includes complete audit trails. Nothing reaches participants without explicit approval from your team. All outputs are editable and reviewable.
How do you handle AI safety?
Our AI operates within strict, contained boundaries — not as an open-ended language model. It transforms and retrieves from your specific documents only. It cannot provide medical advice, make claims beyond your source materials, or generate content outside the scope of the uploaded documents. Every output includes source attribution.
For Buyers
Who typically buys Clear Trials?
Our primary buyers are CROs (typically VP of Clinical Operations or site management leadership) and sponsors (clinical operations teams). Research sites can also implement directly. The platform is especially valuable for mid-size CROs looking to differentiate with sponsors.
How does pricing work?
Clear Trials is priced per study with volume considerations. We offer pilot programs so you can see results before committing to a broader rollout. Contact us to discuss your specific needs.
Can we pilot it on a single study first?
Yes — that is our recommended approach. Most customers start with a single study to validate the workflow, measure impact, and build internal buy-in before expanding.
What results can we expect?
Research shows that participants who understand their trial are 2.2x less likely to drop out. Our platform is designed to improve comprehension, reduce repetitive coordinator questions (coordinators typically spend 5–8 hours each week on these), and give participants 24/7 access to trial information. We measure engagement, comprehension signals, and coordinator time savings.
How does this integrate with our existing systems?
The standard implementation requires no system integration — you upload documents and distribute access codes. For deeper integration with your CTMS, EDC, or document management systems, we offer API-based connections. Contact us to discuss your specific tech stack.
For Participants
How do participants access Clear Trials?
Participants receive an access code from their study coordinator. They enter the code at our secure portal to access their trial-specific information — plain-language summaries, timelines, Q&A, and contact information.
Can participants share access with caregivers or family?
Yes. Participants can share read-only access with caregivers, family members, or anyone in their support network. This is a key differentiator — the people supporting participants through their trial can see the same clear, accessible information.
Is participant data collected?
Clear Trials does not collect PHI. We track anonymized engagement metrics (such as which sections are viewed and which questions are asked) to provide comprehension signals to the study team. See our privacy policy for full details.
Still have questions?
We'd love to walk you through a demo and answer anything specific to your organization.