Digital Health Solutions

YOUR DOORWAY INTO THE DIGITAL HEALTH UNIVERSE

Meditrial partners with companies to navigate the digital health landscape to develop effective regulatory and clinical strategies and tools to support market access.

Meditrial can assist you in demonstration of real-world performance or your device through smart and efficient study design and execution.

You can leverage Meditrial’s medical app tools to capture critical clinical data for your device or drug product.

STRATEGY AND REGULATORY SUPPORT

  • SaMD intended use definition
  • Classification determination
  • Clinical Decision Support determination
  • FDA Guidance and policy interpretation
  • Q-Subs and meetings with Regulators
  • Reimbursement Strategy

DATA AND ANALYTICS

  • Identification of data sets for training algorithm
  • Analytics
  • Utilization of Catchtrial and other Meditrial digital tools

CLINICAL TRIALS WITH DIGITAL HEALTH TOOLS

  • Study design
  • Study execution
  • Real world performance
  • Demonstration of intended use and clinical utility

PRODUCT DEVELOPMENT

  • MMA – customized app for clinical trials
  • ePRO, eCOA, eConsent
  • Cybersecurity and data integrity
  • GMLP (Good Machine Learning Practices)