Compliance & Validation — Documented
SOC 2 Type II, ISO 27001, 21 CFR Part 11, GDPR, HIPAA
Cloud EDC and unified eClinical platform (eCOA, eConsent, RTSM) focused on fast study builds for early-phase and mid-size trials.
Medrio, founded in 2005 and headquartered in San Francisco, California, was among the first cloud-based electronic data capture systems and now offers a unified suite spanning EDC, eCOA/ePRO, eConsent, and RTSM aimed at early-phase and mid-size pharma, biotech, CRO, and medtech trials. The company reports over 600 customers and emphasizes no-code study builds. Its compliance page documents SOC 2 and ISO 27001 alongside self-declared alignment with FDA 21 CFR Part 11, GDPR, and HIPAA; audited certifications should be distinguished from self-assessed compliance during review.
64% — Partial coverage. Coverage score — how completely Atlas documents Medrio across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
SOC 2 Type II, ISO 27001, 21 CFR Part 11, GDPR, HIPAA
cloud
Ask the vendor: What is your pricing model, and what drives total cost of ownership?
Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?
Biotech Startup, Mid-Size Biotech, CRO / CDMO, Clinical Operations, Data Management
Clinical Data Management
Private, Founded 2005
Not captured in Atlas data — confirm directly. Excluded from the score above.
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?