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SPECIFICTION
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BSI CTMS

bsi-lifesciences.com

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Visit bsi-lifesciences.com
Spec score 7.5 #2 of 15 in Clinical Trial Management

What it is

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.

Spec sheet

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.Read 7 Oct 2026 · bsi-lifesciences.com
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.Read 7 Oct 2026 · bsi-lifesciences.com
Headquarters
Baden, SwitzerlandRead 23 Sep 2026 · bsi-lifesciences.com
Founded
1996Read 23 Sep 2026 · bsi-lifesciences.com
EDC partners
The vendor's EDC partner page lists Greenlight Guru, Marvin, Viedoc, and Zelta by Merative.Read 7 Oct 2026 · bsi-lifesciences.com
eTMF
The integrated eTMF supports document workflows for creating, reviewing, approving, and electronically signing documents, with version management and access for study partners.Read 7 Oct 2026 · bsi-lifesciences.com
Hosting
BSI CTMS is offered as software as a service in the BSI Cloud.Read 7 Oct 2026 · bsi-lifesciences.com
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.Read 7 Oct 2026 · bsi-lifesciences.com
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.Read 7 Oct 2026 · bsi-lifesciences.com
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.Read 7 Oct 2026 · bsi-lifesciences.com
Purpose and audience
BSI CTMS supports clinical trial management for pharma, biotech, diagnostics and med-tech sponsors, CROs, and academic organizations.Read 7 Oct 2026 · bsi-lifesciences.com
Reporting
Users can create customized reports from CTMS data and export them to Word, Excel, or PowerPoint.Read 7 Oct 2026 · bsi-lifesciences.com
Support and rollout
BSI offers support during configuration and rollout and can recommend certified systems integrators.Read 7 Oct 2026 · bsi-lifesciences.com
Trial operations
It supports study planning, milestones, patient recruitment and randomization status, site monitoring, issue tracking, and site and investigator management.Read 7 Oct 2026 · bsi-lifesciences.com
Unified platform
The platform combines CTMS, eTMF, study startup, and trial supply management in one system.Read 7 Oct 2026 · bsi-lifesciences.com

Plans and prices

BSI CTMS Priced on request Pricing not stated on the pages reviewed; contact BSI Read 7 Oct 2026 · bsi-lifesciences.com

Every BSI CTMS plan and price →

Strong points and limits

Strong points

  • Combines CTMS, eTMF, startup, and supply management
  • Supports milestone, recruitment, site, and investigator tracking
  • Includes electronic signatures and version management
  • Exports custom reports to Word, Excel, or PowerPoint
  • Offers listed EDC and directory interfaces

Limits

  • Pricing is available only on request
  • Delivered as cloud software, not self-hosted
  • No trial duration is stated

Who it suits

BSI CTMS suits sponsors, CROs, and academic organizations managing clinical trials. It is aimed at teams needing combined trial operations, eTMF, monitoring, supply, and training functions in a cloud service.

Verdict

BSI CTMS brings core trial operations and document management into one BSI Cloud platform. Its listed integrations, monitoring workflows, reporting exports, and compliance specifications will matter to regulated trial teams, while buyers must request pricing.

Where Specifiction places it

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