BSI eTMF:
The eTMF you can afford

BSI eTMF delivers comprehensive functionality for all aspects of trial master file management for your clinical trials: from study startup, to execution, flexible reporting and closing. Full support of your own TMF structure or the TMF Reference Model from DIA with controlled access for all study partners e.g. sponsors, CRO and sites. Setup document plans and track the creation, reviewing and approval process with enhanced alerting functions. BSI eTMF provides real-time audit and inspection readiness.

With the modern HTML5 web-based user interface, BSI eTMF is one step ahead regarding optics and ergonomics. The feedback that we have received is, that the intuitive interface and the intelligent functions in BSI eTMF make our customers’ daily work easier and more efficient, and that it’s a product that they actually enjoy using. We are confident you’ll find BSI eTMF just as delightful and indispensable.

Due to the BSI standardized and proven processes BSI eTMF can be made available for new customers within very short time. BSI supports the customer during configuration and rollout, no external system integrators are required.

BSI eTMF is not only attractive when it comes to functionality and usage, but also in 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 with no dependencies on vendors. Upgrades to new standard versions are offered at very low fix prices. By the way, we would never force you to upgrade if you don’t want to! And no additional license costs if you decide for the combination of BSI eTMF integrated with BSI CTMS!

You decide if BSI eTMF shall be hosted in the cloud by BSI or on-premise on your own IT infrastructure, it is up to you! You can even start in the BSI cloud in order to speed up the project implementation and then later change to on-premise hosting. No vendor locking using BSI eTMF.

Regulatory requirements from 21 CFR Part 11, ICH-GCP E6(R2) and GDPR (General Data Protection Regulation) present major challenges to life science in the areas of patient safety, data protection and security. It is good to know that BSI eTMF is specified and validated according to the regulatory and data protection requirements.

Besides your own access as sponsor or CRO, you can allow controlled access for all study partners, e.g. sites and vendors; And of course, also for inspectors and auditors. This thanks to the sophisticated access right and granting system of BSI eTMF.