MedTech compliant data management

Features to ensure GCP and ISO 14155:2020 compliance

Query Management 

Converse on study endpoints with collaborators and communicate via Query Messages.
Full trail of corrections made to the data and a full overview of all Queries.

  • Raise queries with validation rules 
  • Stay up to date with in-app and email notifications
  • Detailed status of all queries in Study Query List
  • Manual and automatic query functionality

Data Verification

Improve data consistency and validity with SMART-TRIAL’s monitoring and verification types. “Verification I & Verification II”. Perform Source Data Verification, remote monitoring and site monitoring.

  • Customizable Naming .e.g. Remote monitor
  • Verify Forms or individual data points
  •  Permission based verifications

Locking for Data Analysis 

Lock data when quality assurance has been performed to secure data for analysis. 

  • Lock individual data events
  • Database locking 

Data Export at any time

Get a quick overview of your Subject population, export data when needed and get a complete overview of site compliance and subject response rates. Supports statistical tools such as SPSS, SAS, STATA, R, Matlab, MS Excel and more.

  • Export data by site or whole study
  • GDPR compliant export
  • Custom export labels