Clinical Trial Management System (CTMS)

The BSI CTMS delivers comprehensive functionality for all aspects of clinical trials, from study startup to execution, flexible reporting, and closing. It also offers site and investigator management, comprehensive site monitoring including feasibility portal, integrated active trial master file (eTMF), and trial supply management (TSM). The BSI CTMS is suitable for local, regional and global trials and supports interventional as well as non-interventional studies. It has everything you need in one software application, individually configured to your organization’s needs.

With its modern HTML5 web-based user interface, the BSI CTMS is ahead of the curve in optics and ergonomics. The feedback is unanimous: the BSI CTMS’ intuitive interface and intelligent functions make our users’ daily work easier and more efficient. It’s a product that they actually enjoy using. We’re confident that you’ll find the BSI CTMS both easy to use and indispensable.

Due to the BSI’s standardized processes, the BSI CTMS is quickly integrated into your daily routine. BSI offers full support during configuration and rollout or we can recommend one of our certified systems integrators. As the central “hub” and backbone for your clinical trials management, the BSI CTMS allows easy integration with other clinical systems. Standard interfaces are available to integrate with Veeva eTMF, EDC systems, portfolio and project management tools, clinical data warehouses, active directory for single-sign-on, and more.

BSI CTMS is not only attractive when it comes to functionality and use, 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 included in the SaaS license fees.

The BSI CTMS empowers every user with our unique flexible reporting functionality. Create your individualized reports using all available data in the BSI CTMS and export  data to Word, Excel and PowerPoint. Looking for a quick option? You can also use our pre-configured report settings!

Regulatory requirements from 21 CFR Part 11, ICH-GCP E6(R2), EMA/INS/GCP/112288/2023 and GDPR (General Data Protection Regulation) are vital parts of supporting patient safety, data protection, and security. The BSI CTMS is specified and validated according to these regulatory and data protection requirements. Regular updates ensure continued compliance.

Alongside your trials, the BSI CTMS allows you to plan and manage all other projects and assignments. The system includes modules for business development, contract and activity management, as well as invoice tracking and human resource management recording. With these integrated features, the BSI CTMS becomes a real ERP system for contract research organizations (CROs).