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

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

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