The BSI eTMF: The Most Functional and Affordable eTMF Solution for Your Trial Master File Management
The BSI eTMF (electronic Trial Master File) offers a trend-setting, streamlined interface and complete trial master file management functionality. It perfectly supports pharma, biotech, MedTech (medical device and in vitro diagnostics) sponsors, as well as CROs and academics (SMOs).
The BSI eTMF is an exceptional daily tool for trial master file management, always audit and inspection ready. It includes frequent updates and developments based on market and regulatory requirements, and in close collaboration with our existing customers. If you’re looking for an affordable but powerful eTMF solution, BSI is the right partner for you.

BSI eTMF Factsheet
Everything you need to know about the BSI eTMF on two pages. Short, sweet, and to the point.
Companies that count on BSI Life Sciences
Why Switch to BSI's electronic Trial Master File?
Why is the BSI eTMF the right solution for your team? Our customers say it best: they’re thrilled with their choice. We would be happy to organize a reference call with them.
Here are seven powerful reasons to switch to BSI CTMS:
The BSI eTMF delivers comprehensive functionality for all aspects of trial master file management in your clinical trials. From study startup to execution, flexible reporting and closing, the BSI eTMF has you covered. It offers full support of your own TMF structure or the TMF Reference Model from CDISC with controlled access for all study partners. These could include sponsors, CROs and sites. Set up document plans and track the creation, reviewing, and quality approval process with enhanced alerting functions. The BSI eTMF provides real-time audit and inspection readiness.
With its modern HTML5 web-based user interface, the BSI eTMF is one step ahead in optics and ergonomics. Our users tell us that the intuitive interface and the intelligent functions in BSI’s eTMF make their daily work easier and more efficient. It’s a product that they actually enjoy using. We’re confident you’ll find the BSI eTMF just as delightful and indispensable.
Onboarding the BSI eTMF is quick and easy. This is due to standardized and proven processes, available pre-configurations, and templates for medical device and pharma studies. BSI supports customers every step of the way, from configuration, implementation and after roll out.
The BSI eTMF is top in functionality, usage, and operation. The intuitive user guidance keeps training costs minimal while the easy operation supported by processes accelerates data entry. The open software architecture makes sure that you receive future-oriented innovative software without depending on outside vendors. Upgrades to new standard versions are included in the SaaS license fees.
With the BSI Portal you can provide access to BSI eTMF for your study sites and investigators. This allows efficient and easy uploads of all relevant site documents for the sponsor’s trial master file. The sites can download relevant documents and perform document trainings.
Regulatory requirements from 21 CFR Part 11, ICH-GCP E6(R2), EMA/INS/GCP/112288/2023 and GDPR (General Data Protection Regulation) can present major challenges to life science companies. We all want to keep our patients’ data safe, secure, and protected. The BSI eTMF is specified and validated according to all regulatory and data protection requirements.
In addition to accessing the BSI eTMF as a sponsor or CRO, you can allow controlled access for all study partners. This could include sites, vendors, inspectors, and auditors. With the sophisticated access rights and granting system of the BSI eTMF, adding new users is quick, easy, and secure.

BSI eTMF Functions
The BSI eTMF stands out with its comprehensive functionality, providing trial master file management, document plans, reviews and approvals, exports, archiving, and more. We combine comprehensive functionality with a sophisticated granting and access rights system.