Compliance & Validation — Documented
GxP validated, 21 CFR Part 11, HIPAA, GDPR
Clinical ink
eSource and eCOA platform capturing clinical trial data electronically at the point of care.
Clinical ink, founded in 2007 and headquartered in Winston-Salem, North Carolina, provides eSource, eCOA and direct data capture technology for clinical trials, replacing paper-first workflows at research sites. GI Partners, a private equity firm, is the primary investor, and the company operates under its own brand. Its compliance page states conformance to FDA 21 CFR Part 11, HIPAA, EU GDPR, ICH GCP E6 (R2) and GAMP 5 — these are self-declared conformance statements rather than third-party certificates, so confirm which are backed by independent audits.
- Headquarters
- Winston-Salem, United States
- Founded
- 2007
- Compliance
- 21 CFR Part 11, HIPAA, GDPR
- Deployment options
- cloud
- Website
- https://www.clinicalink.com
- https://www.linkedin.com/company/clinical-ink
Categories
AI Use Cases
- Clinical Data Management
- Digital/Decentralized Trials
Vendor Scorecard
64% — Partial coverage. Coverage score — how completely Atlas documents Clinical ink across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud
Pricing Transparency — Not documented by Atlas
Ask the vendor: What is your pricing model, and what drives total cost of ownership?
Implementation & Onboarding — Not documented by Atlas
Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?
Organization & Role Fit — Documented
Mid-Size Biotech, Large Pharma, Top 20 Pharma, CRO / CDMO, Clinical Operations, Data Management
Solution Scope — Documented
Clinical Data Management
Company Viability — Partially documented
Private equity, Founded 2007
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?
Questions to Ask This Vendor
- Which stated compliance frameworks are backed by third-party audit reports or certificates?
- What does site onboarding and training look like for eSource capture?
- How does direct data capture integrate with our EDC and data management stack?
- What validation documentation is provided for regulated use?