Upload your protocol PDF and let AI generate your CRFs, visit schedule, and study structure. Review, adjust, and go live. 21 CFR Part 11 compliant.
AI clinical trial software uses large language models and structured data extraction to automate the most time-consuming parts of study setup. Instead of manually building every CRF field, visit window, and branching rule from scratch, you describe your protocol or upload the PDF and the AI generates a working study structure for you to review and refine.
Capture.Study's AI Study Builder reads your protocol document and outputs eCRFs, visit schedules, inclusion/exclusion criteria forms, and edit checks aligned with your design. You keep full control — every AI suggestion can be edited, removed, or overridden before anything goes live. The result is a study that would take a data manager a week to build, ready in under an hour.
Manual study configuration costs weeks of expert time and thousands of dollars. AI changes that equation entirely.
The Old Way
With Capture
Ready to let AI do the heavy lifting?
How It Works
No implementation team. No kickoff calls. No waiting.
Drop your protocol PDF or paste your synopsis. The AI reads your objectives, endpoints, visit schedule, inclusion/exclusion criteria, and assessment windows.
Capture generates a draft study with CRFs, visit structure, and branching logic. You review every field, edit what needs changing, and approve the final design.
Once you approve, activate your study. All AI-generated content carries a full audit trail. Nothing goes live without your sign-off.
Platform
AI-native from the ground up. Every feature below works with your protocol from day one.
Upload a protocol PDF and AI generates your complete study structure: CRFs, visit schedule, branching logic, and edit checks. Review and approve before anything goes live.
AI reads your endpoints and assessments and creates structured eCRF fields with appropriate types, validation rules, and coding. No manual field-by-field entry.
AI identifies conditional logic in your protocol — skip patterns, eligibility branches, follow-up triggers — and builds the rules automatically.
AI parses your visit schedule table and creates the full timeline with windows, required forms per visit, and coordinator task lists.
AI generates structured eligibility screening forms from your I/E criteria list with correct field types and mandatory flags.
From protocol upload to a testable study in under 10 minutes. No vendor implementation, no kickoff calls, no waiting for a build team.
Every AI output is presented for your review before activation. You edit, approve, or reject any suggestion. The AI assists — you decide.
Every AI-generated field, rule, and structure is logged in the audit trail with a system timestamp. Inspectors can see exactly what was generated vs. manually edited.
Export your AI-generated study design as a specification document or data dictionary. Useful for validation packages and regulatory submissions.
During data collection, AI flags unusual patterns — outlier values, incomplete visit sequences, inconsistent responses — before they become queries.
AI learns from your approved study designs and suggests reusable components for related protocols. Build your second Phase 1 in a fraction of the time.
AI-generated content is subject to the same validation, audit trail, and access controls as manually built content. Compliance is not optional.
All features included. No modules to buy separately.
AI-generated content in Capture.Study is subject to the same 21 CFR Part 11 controls as anything built manually. Every suggestion is logged, every approval is signed.
When AI generates a field, rule, or visit structure, the action is recorded with a system identity and timestamp. When you approve or edit it, your identity and timestamp are recorded. Inspectors see the complete history — AI suggestion, human review, final approval.
Why Capture
A typical Phase 1 study takes a data manager 3–5 days to build from scratch. With the AI Study Builder, the same study is ready to review in under an hour. You spend your time reviewing and approving, not building.
The AI generates, you approve. Nothing goes into your live study without your explicit sign-off. This is not autopilot — it is a very fast assistant.
The AI Study Builder is built into the same Capture.Study interface you use for everything else. Upload a protocol, review the output, click approve. That is the whole workflow.
Sponsors and CROs can validate AI-generated study configurations using the same UAT and documentation process as manually built studies. We provide validation support for Enterprise customers.
Procurement teams at biotech and pharma companies are actively evaluating AI-native clinical platforms. Capture.Study is one of the first EDCs to integrate AI at the study-build level, not just as a reporting overlay.
Upload your protocol, review the output, and go live faster than any EDC team you have worked with.
No credit card. No sales call. No commitment.