Compliant Prospective PMCF Data Collection

The first PMCF tool specifically designed to tackle prospective and case-based data collection for post-market clinical follow-up (PMCF) under the MDR

Why Use

Traditional EDC systems are designed for generic data entry, in strict clinical trial processes. This results in limited compliance and traceability.

SMART-TRIAL Cases is designed specifically to ensure simple and compliant prospective and case-based PMCF data collection.

  • Doesn't overburden clinical staff
  • Provides GCP and GDPR compliance when needed
  • Supports both prospective and retrospective data collection
  • Provides user identification to document the origin of data

Which Data-Types Can be Collected?

SMART-TRIAL Cases has no limits to what can or cannot be collected. Manufacturers can design their own forms and processes to how and when data is collected.

  • Case-reported outcomes
  • Clinical experience & feedback
  • Vigilance
  • Usability

Want to Know More?

Check out our blog with insights on SMART-TRIAL Cases or watch our product webinar with an expert walkthrough of the functionalities as well as interesting use cases.