Product Overview
BSI eTMF (electronic Trial Master File) offers a trend-setting interface and complete trial master file management functionality. It perfectly supports pharma, biotech, MedTech (medical device and in vitro diagnostics) sponsors, as well as CRO and academics (SMO) in their daily work for trial master file management, always being audit and inspection ready. BSI eTMF is being constantly further developed, based on market and regulatory requirements, and in close collaboration with our existing customers. If you are looking for an affordable yet powerful eTMF solution, BSI is the right partner for you.
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
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.
About the company
Founded in 1996. Specializing in state-of-the-art software for life sciences. At home in Switzerland, Germany and USA, or wherever you would like us to be. Private ownership, with employees being part owners. No hierarchies. Our success is based on strong values, best in class products and first-rate employees. That’s who we are.