The Leading European MedTech eClinical Suite
BSI CTMS is the backbone of your future clinical trial management. Plan, track and monitor all your pre- and post-market studies with complete oversight of all study relevant data in one system due to the seamless integration with SMART-TRIAL EDC.
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. Perform regular quality control of all study documents.
The need for electronic data capture and eClinical Suite solutions is vastly increasing as the MDR & IVDR deadlines are approaching.
But how can an eClinical Suite help MedTech companies ensure simplified and compliant clinical data gathering and management?