eTMF

BSI eTMF is a user-friendly electronic Trial Master File solution developed by BSI Life Sciences, a unit of BSI Business Systems Integration AG — a Swiss software company with over 25 years of experience in life sciences software. Designed to simplify the management of clinical trial documentation, BSI eTMF is available either as a stand-alone solution or as an integrated component of the broader BSI CTMS platform, making it suitable for pharma and biotech sponsors, CROs, diagnostics and medical device companies, and Academic Site Management Organizations (SMOs).

BSI Life Sciences is known for delivering innovative, elegant, and user-friendly software that helps clinical teams optimize their development processes. With offices in Switzerland, Germany, and the United States, and a team of 500+ employees, BSI combines deep industry expertise with a practical, cost-effective approach to eClinical software.

Key Benefits of BSI eTMF

• Easy to train, learn, and use, minimizing onboarding time for clinical teams
• Available with the standard reference document structure or configurable to any other structure to meet specific study needs
• Simplifies the exchange of documents with study centers and sites
• Facilitates compliance with all relevant legal, security, and data protection requirements
• Offers an excellent price-to-performance ratio, making it accessible for organizations of varying sizes
• Available as a stand-alone eTMF solution or as a fully integrated component of the BSI CTMS

BSI CTMS Platform — Broader Ecosystem

• Encompasses CTMS, eTMF, Study Startup, LMS (Learning Management System), and TSM (Trial Supply Management) in a single integrated platform
• Features smart data visualization for easy usage and oversight across all clinical trial phases
• Simplifies the management of study team, site, and sponsor access rights
• Integrates easily with existing systems using standard APIs
• Offers comprehensive and customizable reporting capabilities through pure configuration, without the need for custom development

Stakeholder-Specific Capabilities

• Pharma & Biotech: Supports planning and management of all aspects of clinical trials across multiple phases for sponsor organizations
• Diagnostics & Medical Devices: Includes additional modules for sample and medical device tracking, designed to accommodate any study type
• CROs: Provides specific modules for business development, budgeting, and activity management alongside the core CTMS and eTMF functionality
• Academic SMOs: Offers a comprehensive CTMS and eTMF solution tailored to the needs of Academic Site Management Organizations

BSI eTMF and the broader BSI CTMS platform are developed and maintained by BSI Life Sciences, headquartered in Switzerland with a presence across Germany and the United States. The platform is built to meet legal, security, and data protection compliance requirements, and integrates with existing clinical and enterprise systems via standard APIs.