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 get 24/7 access to these simplified materials, a visual timeline, a Q&A tool sourced from their actual documents, and study contact information. They can also share read-only access to the materials with caregivers and family.
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?
Not a general-purpose one. The participant-facing Q&A uses AI to write an answer from passages retrieved from that study’s approved documents, and cites them. It is designed not to answer from general knowledge or give medical advice, and questions the documents can’t answer go to the coordinator. Like any AI, it can make mistakes, so participants are told to check with their study team. Every AI-generated summary is reviewable and editable by your team before participants see it.
What documents does Clear Trials work with?
Send us the documents you already give participants: informed consent forms, study guides, visit instructions and other participant-facing materials. There is nothing to connect to your document management system.
How long does implementation take?
Most implementations are live in weeks, not quarters. You send us your documents, review the AI-generated summaries, and distribute access codes to participants. No IT integration is required.
Compliance & Security
Does this require IRB approval?
Clear Trials works from your existing IRB-approved materials and does not change the original documents. The plain-language summaries and answers are new participant-facing content, and study staff and sponsor reports can see what participants ask, so plan to include Clear Trials in your IRB submission. We provide documentation to support that review.
How does Clear Trials handle HIPAA?
When a research site covered by HIPAA uses Clear Trials, information such as enrollment and visit details and the questions participants ask is Protected Health Information (PHI). For that information, Clear Trials acts as the site’s Business Associate and signs a Business Associate Agreement with it. Our Security page shows which of our own vendor agreements are in place today and which are in progress, and our privacy policy has the details.
What about ICH-GCP compliance?
Clear Trials is designed to support ICH-GCP compliance. Changes to study documents and enrollment records are written to an append-only audit log. Content drawn from your documents is approved by your team before participants see it, and all of it is editable.
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, and it is designed not to give medical advice, make claims beyond your source materials, or generate content outside the scope of the uploaded documents. Every answer cites its source, and questions the documents cannot answer go to the coordinator.
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. Start with a single study to validate the workflow, see what participants ask, and build internal buy-in before expanding.
What results can we expect?
We do not promise a dropout or retention figure. What you get is 24/7 answers for participants from their own study documents, and a count of what they ask between visits for each study site: the topics they return to, and what their documents could not answer. A pilot is where we measure what changes for your study.
How does this integrate with our existing systems?
It does not, by design. You send us the documents you already give participants, and we send back an enrollment code. There is no connection to your CTMS, EDC or document management system, and no ongoing software management for your sites. Questions routed to the coordinator arrive by email.
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?
Yes. Clear Trials collects what it needs to provide the service. Your study team at your research site can see your name, the questions you ask, and how you use the app, so they can support you. Study reports for the sponsor or CRO leave out your name and email address but can include questions as you wrote them. Our privacy policy lists what we collect and who can see it.
Still have questions?
We'd love to walk you through a demo and answer anything specific to your organization.