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Combine BSI CTMS and eTMF with EDC for Clinical Investigations

The Leading European Med-Tech eClinical Suite

Streamline data between BSI CTMS and the Electronic Data Capture (EDC) solution from our partner SMART-TRIAL.

The SMART-TRIAL EDC platform is designed to streamline the collection and management of clinical data so safer and better medical devices can reach healthcare faster.

SMART-TRIAL makes it easy and cost-effective to collect and manage clinical data in compliance with MedTech industry regulations.

  • Intuitive drag-and-drop form creator
  • Ready-to-use form validation
  • GCP compliant data management and monitoring
  • Standardized data collection with help text and custom labels
  • Advanced validation rules on individual questions
  • Complete audit logging and change management

The need for an eClinical suite is vastly increasing as the MDR & IVDR deadlines are approaching. But how can the MedTech eClinical Suite from BSI and SMART-TRIAL ensure efficient and compliant trial management and clinical data gathering

Get your free whitepaper here

The five ways a MedTech eClinical Suite helps you with MDR and IVDR compliance


Merative (formerly IBM Watson Health) and BSI Life Sciences: Strong eClinical Suite for Life Sciences

Expertise to meet your needs. Whether you need a self-service solution or full-service consulting, the integration between BSI CTMS and Merative (formerly IBM Clinical Development) helps you overcome common challenges in clinical trials.

Merative can help you:

  • Design, validate and launch studies and apply amendments without database migration, EDC
  • Build and automate data connectors with minimal coding, Data Integration
  • Use pre-built or custom reports to derive single and cross-study insights, Reporting and analytics
  • Increase efficiency by leveraging AI to build consistency and reduce errors, Medical coding using AI
  • Design and manage randomization in a single interface with minimal coding required, Randomization and Trial Supply Managment (RTSM)
  • Strengthen patient centricity with easier trial participation, Patient engagement (ePRO) and BYOD
  • Compile, manage and reconcile with ease by leveraging automation, Endpoint adjudication

Next Best Action:

BSI Life Sciences




Jan Nielsen,
Community Manager Life Sciences

+41 58 255 96 22