Compliance & Validation — Documented
HIPAA, SOC 2 Type II, GDPR
Unlearn.AI
Digital twin technology for clinical trials to reduce placebo arm size and accelerate evidence generation.
Unlearn creates prognostic digital twins for each clinical trial participant using machine learning trained on historical data. These digital twins simulate the expected disease progression of patients, enabling smaller, faster, more efficient trials. Their TwinRCT approach has been validated across multiple therapeutic areas including Alzheimer's disease and multiple sclerosis.
- Headquarters
- San Francisco, United States
- Founded
- 2017
- Compliance
- HIPAA, SOC 2 Type II, GDPR
- Deployment options
- cloud
- Website
- https://www.unlearn.ai
- https://www.linkedin.com/company/unlearn-ai
Categories
AI Use Cases
- Digital/Decentralized Trials
- Protocol Design Optimization
Vendor Scorecard
100% — Complete coverage. Coverage score — how completely Atlas documents Unlearn.AI across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud
Pricing Transparency — Documented
Per study
Implementation & Onboarding — Documented
3–6 months
Organization & Role Fit — Documented
Biotech Startup, Mid-Size Biotech, Large Pharma, Clinical Operations, R&D Leadership, Data Management
Solution Scope — Documented
Patient Recruitment, Trial Protocol Optimization
Company Viability — Documented
Series C, $50.0M raised, 90+ employees, Founded 2017
Always ask the vendor
Not captured in Atlas data — confirm directly. Excluded from the score above.
Data Rights & IP
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Model Credibility & Explainability
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?
Evidence & Outcomes
EMA qualification opinion for PROCOVA prognostic-covariate digital-twin method
The European Medicines Agency issued a qualification opinion on PROCOVA, the prognostic covariate adjustment methodology underpinning Unlearn's digital-twin approach, supporting its use to increase statistical efficiency in randomized controlled trials.
regulatory filing (European Medicines Agency) · 2022-09-01
Questions to Ask This Vendor
- Which regulatory agencies have accepted TwinRCT in submissions?
- What sample size reduction can we realistically expect in our indication?
- How are digital twin models validated against held-out trial data?
- What data standards (CDISC/HL7) do you require?