Delineate
FreemiumAI-powered clinical trial design agents for faster protocol creation.
By Tanmay Verma, Founder · Last verified 03 Jul 2026
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Added 7d ago
77/100Safe BetIn short
Delineate — AI-powered clinical trial design agents for faster protocol creation. Best for Clinical researchers streamlining protocol creation, Biostatisticians generating adaptive trial designs, Clinical operations managers forecasting patient enrollment. Free to start; paid plans from $99/mo.
Is Delineate actually worth it?
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Editorial Verdict
Best for
Clinical researchers streamlining protocol creationBiostatisticians generating adaptive trial designsClinical operations managers forecasting patient enrollmentRegulatory affairs specialists compiling compliance checklistsMedical writers producing submission-ready protocol summaries
Not ideal for
Patients seeking treatment information or clinical trial enrollmentNon-clinical product teams without regulatory expertiseSmall clinics without dedicated research staffTeams needing a full-featured EDC system (Delineate is design-only)
A must-try for clinical teams bogged down in protocol drafting. Its agent-based approach genuinely accelerates study design, though pricing for advanced features may be steep for small sites.
Compare with: Delineate vs Verge Genomics, Delineate vs Deep 6 AI, Delineate vs Schrodinger
Last verified: July 2026
Viability Score
77/100
Safe BetHow likely is Delineate to still be operational in 12 months? Based on 4 signals — momentum (how recently it shipped), wrapper dependency, revenue model, and web presence.
momentum
55
funding runway
80
website health
90
wrapper dependency
100
Last calculated: July 2026
How we score →Key Features
- Multi-agent clinical trial design
- Protocol outline generation
- Patient enrollment forecasting
- Endpoint selection rationale
- Regulatory compliance checklists (FDA, EMA, ICH)
- Literature search and evidence synthesis
- Feasibility assessment reports
- Export to Word, PDF, and CDISC SDTM format
- Adaptive trial design templates (Bayesian dose-finding)
- Rare disease agent workflows with natural history comparisons
- Custom agent building via no-code editor
- API access for enterprise integrations (Professional plan)
- Version control and audit trail
- Real-time collaboration for design teams
- Therapeutic area-specific templates (oncology, neurology, rare diseases)
About Delineate
FreemiumAdvancedAPI availableWeb
Delineate automates clinical trial design using specialized AI agents. Tailored for clinical researchers, biostatisticians, and drug developers, it slashes protocol creation from weeks to minutes. The multi-agent architecture handles literature review, endpoint selection, and regulatory checklist generation. Recent updates include adaptive trial design templates for dose-finding studies and rare disease-specific workflows using natural history comparisons. A new Professional plan (April 2026) unlocks API access and custom agent workflows. Unlike generic AI writing tools, Delineate integrates with eClinical platforms (Medidata, Veeva) and exports to CDISC SDTM—built for the regulated clinical trial lifecycle.
Behind the Verdict
We'd reach for Delineate when a mid-size biotech is rushing a Phase II protocol and needs regulatory-ready output fast. The multi-agent design—where distinct agents handle literature, endpoints, and compliance—saves hours of cross-referencing. The April 2026 Professional tier ($499/mo) now offers API access, making it embeddable in custom workflows; that's a real step up for CROs. Where it bites: the Free and Starter plans lack custom agent workflows and API access—most users will outgrow them quickly. Compared to a manual approach or generic writing tools (like ChatGPT), Delineate's clinical domain models produce checklist-specific output (ICH E6, FDA guidance) but don't bring a medical writer's nuance on rare endpoints. Real-world caveat: adoption requires buy-in from regulatory teams who may be skeptical of AI-generated content; plan for review cycles. For academic researchers, the Free tier is a solid starting point.
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Use Cases
- Generate a complete protocol outline for a Phase 2 oncology trial in under 15 minutes.
- Simulate patient enrollment timelines using historical data and site feasibility.
- Automate literature search and evidence extraction for a rare disease protocol.
- Create an FDA-compliant regulatory checklist for an investigator-initiated trial.
- Design an adaptive trial with multiple endpoints using AI-driven recommendations.
- Produce a feasibility assessment report for a multi-site global study.
Limitations
- Free tier limited to 5 trial designs per month.
- Advanced features like custom workflows and API only available on Professional plan and above.
- Currently no mobile app; web-only.
- Trial designs may require manual review for regulatory compliance.
12-month cost
Project the real annual outlay, including the implied monthly cost when only an annual tier is published.
Annual total
Free
Over 12 months
Effective monthly
Free
Billed monthly
Vendor list price only. Add-on usage, seat overages, and contract minimums are surfaced under Hidden costs & gotchas.
Integrations
Medidata Rave EDCVeeva Vault ClinicalTrialMasterOpenClinicaREDCapSASRStudioPubMedClinicalTrials.gov
Resources & Guides
Frequently Asked Questions
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