Compliance & Validation — Documented
ISO 27001, SOC 2 Type II, 21 CFR Part 11, GDPR
Clinical data platform (elluminate) centralizing trial data with AI-enabled review and analytics, plus biometrics services.
eClinical Solutions, founded in 2006 and headquartered in Mansfield, Massachusetts, provides the elluminate Clinical Data Cloud, a platform that aggregates clinical and operational trial data with pre-built connectors, standardized review workflows, and AI-enabled data review (elluminate IQ), complemented by biometrics services. Its trust center documents ISO 27001:2022 and ISO 27701 certification and a SOC 2 Type II report, alongside self-declared FDA 21 CFR Part 11 and GDPR compliance. The company is privately held; software and services are often bundled, so scope the service component during evaluation. In 2024 eClinical Solutions received a majority growth investment from private-equity firm GI Partners.
64% — Partial coverage. Coverage score — how completely Atlas documents eClinical Solutions across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
ISO 27001, SOC 2 Type II, 21 CFR Part 11, GDPR
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?
Mid-Size Biotech, Large Pharma, Top 20 Pharma, CRO / CDMO, Data Management, Clinical Operations
Clinical Data Management
Private equity, Founded 2006
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?