Electronic Data Capture (EDC)

Cut costs on DATA collection and monitoring of clinical trials.

Signifikans offers cost-efficient and user-friendly Electronic Data Capture (EDC) solutions based on OpenClinica Enterprise. OpenClinica, one of the most popular EDC systems in the world, is a fully web-based solution that is in compliance with FDA guidelines on electronic records and electronic signatures (21 CFR Part 11).

OpenClinica Enterprise

  • 100% web-based setup
  • Data entry, monitoring and study management features
  • Integrated validation / edit checks to detect data entry errors
  • Integrated Data Clarification form (DCF) for efficient communicate between investigator, monitor and other participants
  • Complies with FDA 21 CFR Part 11 and Good Clinical Practices (GCP)
  • Formally validated, tested and certified software
  • CDISC compliant (and therefore fully integrated with other databases)
  • Solutions offered on a validated, tested and secure server environment
  • Signifikans offers study setup, hosting and support

Developed by U.S. company Akaza Research with support from the National Institutes of Health (NIH) and used by more than 12.000 organizations around the world.

A demonstration of OpenClinica.

Get timely, high quality patient-reported data directly into the OpenClinica software. Click above for an informative video on OpenClinica Participate.

"Our OpenClinica Enterprise EDC system is cost-competitive, feature-competitive and highly flexible."

Kristoffer Grønnegaard, senior programmer and datamanager