BSI CTMS vs Medidata CTMS
BSI CTMS
bsi-lifesciences.com
Medidata CTMS
medidata.comSide by side
| Figure | BSI CTMS | Medidata CTMS |
|---|---|---|
| Price from | — | — |
| Free plan | — | — |
| Free trial | — | — |
| Open source | — | — |
| Web | Yes | Yes |
| API | Yes | — |
| Plans published | 1 | 1 |
| Spec score · Clinical Trial Management | 7.5 (#2) | 7.0 (#4) |
| Spec score · Research Project Management Software | 7.5 (#9) | 7.0 (#16) |
| Compliance | BSI says CTMS is specified and validated for 21 CFR Part 11, ICH-GCP E6(R2), EMA/INS/GCP/112288/2023, and GDPR requirements. | Medidata lists documentation addressing regulations including ICH E6, 21 CFR Part 11, EU GMP Annex 11, and FDA guidance, with some materials requiring an iMedidata account. |
| Founded | 1996 | 1999 |
| Headquarters | Baden, Switzerland | New York, New York, United States |
| Integrations | The vendor lists standard interfaces for Veeva eTMF, EDC systems, portfolio and project management tools, clinical data warehouses, and Active Directory single sign-on. | CTMS is integrated with Medidata Rave and eTMF; EDC data can populate dashboards and analysis, while uploaded documents and monitoring reports flow to the eTMF or TMF. |
Plans
In their own words
BSI CTMS
BSI CTMS is a cloud-delivered clinical trial management system for pharmaceutical, biotechnology, diagnostics, med-tech, contract research, and academic organizations. Its unified platform combines CTMS functions with an electronic trial master file, study startup, and trial supply management. Teams can plan studies, track milestones, follow recruitment and randomization status, monitor sites, manage investigators, and record issues. The eTMF handles document creation, review, approval, electronic signatures, version management, and study-partner access. Risk-based monitoring, monitoring-visit workflows, offline monitoring, and an integrated learning management system support oversight and training records. Users can build reports from CTMS data and export them to Word, Excel, or PowerPoint. Listed interfaces cover Veeva eTMF, EDC, portfolio and project management, clinical data warehouses, and Active Directory single sign-on. BSI says the system is validated for specified clinical-trial and privacy requirements. Pricing is on request.
Medidata CTMS
Medidata CTMS has no write-up on Specifiction yet; its figures are above.