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BSI CTMS
Baden, Switzerland
What it is
BSI CTMS is paid cloud software for managing clinical trials for pharma, biotech, diagnostics, med-tech sponsors, CROs, and academic organizations. It combines clinical trial management, electronic trial master file, study startup, and trial supply management in one platform. Teams can plan studies, track milestones, monitor recruitment and randomization status, manage sites and investigators, and follow issues and monitoring activity. The eTMF supports document creation, review, approval, electronic signatures, version management, and study-partner access. Monitoring features include risk-based monitoring, electronic-signature visit workflows, and offline monitoring, while an integrated learning management system tracks training. Users can create custom reports and export them to Word, Excel, or PowerPoint. Listed interfaces include Veeva eTMF, EDC systems, project tools, clinical data warehouses, and Active Directory single sign-on. BSI says the system is specified and validated for 21 CFR Part 11, ICH-GCP E6(R2), EMA/INS/GCP/112288/2023, and GDPR. Pricing is available on request.
For and against
For
- Combines CTMS and eTMF
- Milestone and recruitment tracking
- Electronic document signatures
- Offline and risk-based monitoring
- Custom report exports
Against
- Pricing is available on request
- Cloud SaaS deployment
- Configuration and rollout support may be needed
The verdict
BSI CTMS brings broad clinical-trial operations and documentation into one cloud platform. Its reporting, monitoring, integrations, and compliance mappings make it relevant to organizations managing structured study processes.
Who it suits
BSI CTMS suits clinical-trial organizations that need combined trial operations, eTMF, startup, supply, monitoring, and training functions. It is aimed at sponsors, CROs, and academic teams using cloud deployment.
Plans and prices
BSI CTMS
Pricing not stated on the pages reviewed; contact BSI
Read 7 Oct 2026 · bsi-lifesciences.com
On the record
- 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.bsi-lifesciences.com · read 7 Oct 2026
- EDC partners
- The vendor's EDC partner page lists Greenlight Guru, Marvin, Viedoc, and Zelta by Merative.bsi-lifesciences.com · read 7 Oct 2026
- eTMF
- The integrated eTMF supports document workflows for creating, reviewing, approving, and electronically signing documents, with version management and access for study partners.bsi-lifesciences.com · read 7 Oct 2026
- Hosting
- BSI CTMS is offered as software as a service in the BSI Cloud.bsi-lifesciences.com · read 7 Oct 2026
- 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.bsi-lifesciences.com · read 7 Oct 2026
- Maker background
- BSI says it was founded in 1996 and is based in Switzerland, Germany, and the USA; its imprint lists BSI Business Systems Integration AG in Baden, Switzerland.bsi-lifesciences.com · read 7 Oct 2026
- Monitoring and training
- Features include risk-based monitoring, monitoring visit workflows with electronic signatures, offline monitoring, and an integrated learning management system for tracking training.bsi-lifesciences.com · read 7 Oct 2026
- Notable limits
- The vendor says upgrades to new standard versions are included in SaaS license fees; the page does not state a price or trial duration.bsi-lifesciences.com · read 7 Oct 2026
- Purpose and audience
- BSI CTMS supports clinical trial management for pharma, biotech, diagnostics and med-tech sponsors, CROs, and academic organizations.bsi-lifesciences.com · read 7 Oct 2026
- Reporting
- Users can create customized reports from CTMS data and export them to Word, Excel, or PowerPoint.bsi-lifesciences.com · read 7 Oct 2026
- Support and rollout
- BSI offers support during configuration and rollout and can recommend certified systems integrators.bsi-lifesciences.com · read 7 Oct 2026
- Trial operations
- It supports study planning, milestones, patient recruitment and randomization status, site monitoring, issue tracking, and site and investigator management.bsi-lifesciences.com · read 7 Oct 2026
- Unified platform
- The platform combines CTMS, eTMF, study startup, and trial supply management in one system.bsi-lifesciences.com · read 7 Oct 2026
