Freedom251 › Clinical Trial Management
BSI CTMS
What BSI CTMS is
BSI CTMS is a cloud clinical trial management system for pharma, biotech, diagnostics, and med-tech sponsors, CROs, and academic organizations. It combines CTMS, an electronic trial master file, study startup, and trial supply management. Teams can plan studies, track milestones, follow recruitment and randomization status, monitor sites, track issues, and manage investigators. Its eTMF supports document creation, review, approval, electronic signatures, version management, and study-partner access. Monitoring tools include risk-based monitoring, visit workflows with electronic signatures, and offline monitoring; an integrated learning management system tracks training. Users can build reports from CTMS data and export them to Word, Excel, or PowerPoint. BSI lists interfaces for Veeva eTMF, EDC systems, portfolio and project management tools, clinical data warehouses, and Active Directory single sign-on. The vendor says the system is specified and validated for named clinical-trial and privacy requirements, including 21 CFR Part 11, ICH-GCP E6(R2), EMA/INS/GCP/112288/2023, and GDPR. It is offered as SaaS in the BSI Cloud, with rollout support available. Pricing is on request.
Who it suits
It is intended for clinical trial sponsors, CROs, and academic organizations in pharma, biotech, diagnostics, and med-tech. It may suit teams seeking trial operations, eTMF, startup, and supply management in one system.
What it does well
- Combines CTMS, eTMF, startup, and supply management
- Tracks milestones, recruitment status, sites, and issues
- Includes electronic signatures and document version management
- Offers offline monitoring and training tracking
- Exports reports to Word, Excel, or PowerPoint
What to know first
- Pricing is available on request
- The pages do not state a trial duration
Plans
| Plan | Billed and limits | Price |
|---|---|---|
| BSI CTMS | Pricing not stated on the pages reviewed; contact BSI | On request |
As bsi-lifesciences.com lists them, read 7 Oct 2026. The maker's own page has the final word.
Getting started
- Visit the BSI CTMS website.
- Contact BSI to request pricing and discuss the system.
- Arrange configuration and rollout with BSI support.
- Use the BSI Cloud SaaS deployment.
Verdict
BSI CTMS covers trial operations alongside document workflows, monitoring, and training. Organizations should confirm pricing and rollout needs with BSI.
Questions
Who is BSI CTMS for?
It supports pharma, biotech, diagnostics, and med-tech sponsors, CROs, and academic organizations.
What does the platform include?
It combines CTMS, eTMF, study startup, and trial supply management.
How is it deployed?
BSI CTMS is offered as software as a service in the BSI Cloud.
What does it cost?
Pricing is available on request; contact BSI.
What systems can it integrate with?
BSI lists standard interfaces for Veeva eTMF, EDC systems, portfolio and project management tools, clinical data warehouses, and Active Directory single sign-on.
What compliance requirements does BSI cite?
BSI says CTMS is specified and validated for 21 CFR Part 11, ICH-GCP E6(R2), EMA/INS/GCP/112288/2023, and GDPR requirements.
Facts from BSI CTMS's own pages
- 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, 7 Oct 2026
- EDC partners
- The vendor's EDC partner page lists Greenlight Guru, Marvin, Viedoc, and Zelta by Merative. · bsi-lifesciences.com, 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, 7 Oct 2026
- Founded
- 1996 · bsi-lifesciences.com, 23 Sept 2026
- Headquarters
- Baden, Switzerland · bsi-lifesciences.com, 23 Sept 2026
- Hosting
- BSI CTMS is offered as software as a service in the BSI Cloud. · bsi-lifesciences.com, 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, 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, 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, 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, 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, 7 Oct 2026
- Reporting
- Users can create customized reports from CTMS data and export them to Word, Excel, or PowerPoint. · bsi-lifesciences.com, 7 Oct 2026
- Support and rollout
- BSI offers support during configuration and rollout and can recommend certified systems integrators. · bsi-lifesciences.com, 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, 7 Oct 2026
- Unified platform
- The platform combines CTMS, eTMF, study startup, and trial supply management in one system. · bsi-lifesciences.com, 7 Oct 2026
Where BSI CTMS stands on Freedom251
- Clinical Trial Management#3 of 15
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