CTMS

BSI CTMS is a comprehensive, integrated eClinical software platform developed by BSI Life Sciences for planning and managing clinical trials across all phases. Designed to be modern, intuitive, and easy to use, it combines Clinical Trial Management Software (CTMS), electronic Trial Master File (eTMF), Study Startup, Learning Management System (LMS), and Trial Supply Management (TSM) into a single unified solution. BSI Life Sciences has been developing life sciences software for over 25 years, with offices in Switzerland, Germany, and the United States.

The platform is built to serve a wide range of stakeholders in the clinical research ecosystem, including pharmaceutical and biotech sponsors, diagnostics and medical device companies, Contract Research Organizations (CROs), and Academic Site Management Organizations (SMOs). Its flexible architecture and configuration-driven approach make it suitable for organizations of varying sizes and complexity.

BSI CTMS Core Capabilities

• Supports all clinical trial phases with a single, integrated software environment
• Features smart data visualization for easy usage and real-time oversight
• Simplifies the management of study team, site, and sponsor access rights
• Facilitates compliance with all relevant legal, security, and data protection requirements
• Integrates easily with existing systems using standard APIs
• Offers comprehensive and fully customizable reporting capabilities through pure configuration, without the need for custom coding

BSI eTMF Features

• User-friendly interface designed to be easy to train, learn, and use
• Available with the standard reference document structure or any custom structure via configuration
• Simplifies the exchange of documents with study centers and sites
• Facilitates compliance with all relevant legal, security, and data protection requirements
• Can be deployed as a stand-alone solution or as an integrated component within the full BSI CTMS platform
• Offers an excellent price-to-performance ratio

Stakeholder-Specific Modules and Solutions

• Pharma and Biotech: Full CTMS functionality to plan and manage all aspects of clinical trials across all phases for sponsor organizations
• Diagnostics and Medical Devices: Additional modules for sample tracking and medical device tracking, designed to accommodate any study type
• CROs: Dedicated modules for business development, budgeting, and activity management alongside the core CTMS and eTMF solutions
• Academic SMOs: Comprehensive CTMS and eTMF tools tailored to the needs of Academic Site Management Organizations

Trial Supply Management (TSM)

• Supports clinical trial data quality through dedicated trial supply management functionality
• Designed to be paired with a modern CTMS for optimal operational efficiency
• Helps teams manage and track investigational products and supplies throughout the trial lifecycle

BSI Life Sciences is a unit of BSI Business Systems Integration AG, a Swiss private software company founded in 1996 with over 500 employees across 9 offices in Switzerland, Germany, and the United States. The platform is built with a focus on innovative, elegant, and user-friendly design, helping customers continually optimize their clinical development processes while maintaining cost-effectiveness and regulatory compliance.