SynterActive System: A Full-Featured IWRS

Developed by SynteractHCR clinical technology service experts, our SynterActive System platform is validated for compliance with 21 CFR Part 11 and the EU Annex 11: Computerised Systems. Additionally, each project specific system is tested through a combination of automated and manual user acceptance testing (UAT). Full testing documentation (sans any unblinded data) is available upon request. After release, any system modifications which impact the functionality of the system are handled via change control processes and are formally tested.

Below are the common clinical trial processes the SynterActive System supports. Please note the SynterActive System is a web based system and does not have phone/voice capability.

  • Real Time Reporting and Notifications
  • Screening, Enrollment and Subject Status
  • Eligibility Calculations
  • Randomization and Dose Assignment Visits
  • Subject or Data Unblinding
  • IP and Supplies Dispensation, Dose Management, and Dose Calculations
  • IP Supplies Management
  • System Integration
  • Alerts and Caps
  • Support Options and Team Availability

Our team can provide the exact level of functionality required for your clinical trial. Click here for more specifics on our full-featured IWRS capabilities.

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