BSI Business Systems Integration AG

BSI Life Sciences is a Switzerland-based eClinical software company that has been developing clinical trial management solutions for over 25 years. A unit of BSI Business Systems Integration AG — one of Switzerland's most established private software companies — BSI Life Sciences serves pharmaceutical and biotech sponsors, CROs, diagnostics and medical device companies, and Academic Site Management Organizations (SMOs). Their platform is designed to maximize clinical trial logistics through integrated, user-friendly, and cost-effective software tools.

Founded in 1996, BSI has grown to more than 500 employees across nine offices in Switzerland, Germany, and the United States. The company is recognized for its innovative, elegant product design and its commitment to helping customers continually optimize their clinical development processes.

Core Products

• BSI CTMS (Clinical Trial Management Software): An innovative, all-in-one solution supporting all clinical trial phases. It encompasses CTMS, eTMF, Study Startup, LMS (Learning Management System), and TSM (Trial Supply Management) in a single integrated platform.
• BSI eTMF (Electronic Trial Master File): A user-friendly, standalone or integrated solution for managing the Trial Master File, offering an excellent price-to-performance ratio. It supports the reference document structure or any custom structure via configuration, and simplifies document exchange with study centers and sites.

Key Capabilities of BSI CTMS

• Smart data visualization for easy usage and oversight across clinical trial operations
• Simplified management of study team, site, and sponsor access rights
• Facilitates compliance with all relevant legal, security, and data protection requirements
• Easy integration with existing systems via standard API
• Comprehensive and fully customizable reporting capabilities through pure configuration
• Modern architecture with significant advantages over legacy CTMS systems

Key Capabilities of BSI eTMF

• Easy to train, learn, and use for all stakeholders
• Available as a standalone solution or as a fully integrated component of the BSI CTMS
• Configurable document structures to accommodate any study design
• Streamlines document exchange with study centers and sites
• Supports compliance with legal, security, and data protection requirements

Industry-Specific Modules and Solutions

• Pharma & Biotech: Full planning and management of all clinical trial phases through the BSI CTMS platform
• Diagnostics & Medical Devices: Additional modules for sample tracking and medical device tracking, designed to accommodate any study type
• CRO: Specialized modules for business development, budgeting, and activity management alongside the core CTMS and eTMF solutions
• Academic SMO: Comprehensive CTMS and eTMF tools tailored for Academic Site Management Organizations

Company and Deployment Details

• Developed and maintained over more than 25 years, with deep roots in Switzerland, Germany, and the United States
• Part of BSI Business Systems Integration AG, a leader in CRM and marketing automation for insurance, banking, and other industries across Germany and Switzerland
• 500+ employees across nine offices internationally
• Focused on delivering practical, cost-effective solutions that help customers optimize clinical development processes

BSI Life Sciences combines decades of software expertise with a genuine commitment to user-centered design, making it a trusted partner for life sciences organizations seeking modern, integrated clinical trial management technology.