Clinical trial analytics · Dassault Systèmes (Medidata)
Medidata
Cloud platform for electronic data capture, trial management, and analytics used across most FDA drug approval trials.
Medidata provides a cloud-based platform covering the operational lifecycle of a clinical trial: electronic data capture (Rave EDC), clinical trial management (CTMS), randomization and trial supply management (RTSM), safety data exchange, and patient-facing tools for decentralized and hybrid trials. Sponsors and CROs use it to design case report forms, collect and clean patient data from sites, manage study conduct, and layer analytics and AI-assisted quality checks on top of the same governed dataset. It differs from analytics-only vendors in that it is the system of record that actually runs the trial, not a downstream reporting layer. Medidata was acquired by Dassault Systèmes in 2019 and operates as a business unit within it, serving pharmaceutical, biotech, and device sponsors under 21 CFR Part 11 and HIPAA-aligned controls.
At a glance
| Vendor | Dassault Systèmes (Medidata) |
|---|---|
| Pricing model | Quote only |
| Free tier | No |
| Deployment | Cloud |
| Open source | No |
| Best for | Sponsors and CROs running regulated, multi-site trials who need a single system of record from data capture through analytics. |
Pricing
Priced per study through direct negotiation with Medidata/Dassault Systèmes sales; no public price list.
Pricing has not been verified yet — see the vendor's site.
Features
- Electronic data capture (Rave EDC) with configurable case report forms
- Clinical trial management system (CTMS)
- Randomization and trial supply management (RTSM)
- Safety data exchange and pharmacovigilance integration
- Patient-facing apps for decentralized/hybrid trial participation (myMedidata)
- AI-assisted data quality checks and query management
- Risk-based quality management and analytics dashboards
- 21 CFR Part 11 and HIPAA-aligned audit trails
Profile last reviewed September 21, 2026