Compliance & Validation — Not documented by Atlas
Ask the vendor: Which compliance certifications (HIPAA, 21 CFR Part 11, SOC 2, GxP) do you hold?
eCOA and decentralized trial solutions provider collecting patient-reported and clinician-reported outcomes across modalities.
Kayentis, founded in 2003 and headquartered in Meylan, France (Grenoble area), provides electronic clinical outcome assessment (eCOA) and decentralized clinical trial solutions, collecting patient- and clinician-reported outcomes on provisioned devices, bring-your-own-device, and web. It is privately held with growth investment from LBO France and Extens. As with any eCOA provider, per-study validation documentation and instrument licensing should be reviewed for regulated use. Atlas found no vendor-held security certifications documented on its site.
50% — Partial coverage. Coverage score — how completely Atlas documents Kayentis across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Ask the vendor: Which compliance certifications (HIPAA, 21 CFR Part 11, SOC 2, GxP) do you hold?
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, CRO / CDMO, Clinical Operations, Data Management
Clinical Data Management
Private, Founded 2003
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?