OpenClinica V4.0

OpenClinica V4.0 is a fully GCP compliant, all in one platform, cloud-hosted system where the eCRFs are designed in-house by the ICTU Clinical Data Systems Team.

OpenClinica allows for a seamless and integrated user experience through the following modules - Enterprise (EDC), Participate (ePRO and eCOA), Randomize (IVRS and Supply), Insight (Reporting) hosted on the OpenClinica Cloud.

If requesting the use of OpenClinica, please contact

Our Service benefits in OpenClinica V4.0

CDS Services
  • Easy and fast electronic capture through ultra-capable, user-friendly eCRFs
  • Real-time edit checks, skip logic and auto save of data input
  • Full in-built audit trail of data entry and changes
  • On-line data entry, monitoring and data sign-off which supports Clinical Data Management activities
  • Randomisation and Drug Supply Management, track drug kits and monitor inventory
  • Patient reported outcome (ePRO and eCOA)
  • Reporting of operational and clinical data in real time
  • Data extracts of the data for analyses
  • Disaster recovery provision
  • Supports compliance with legislation and regulatory guidance on clinical research management
CDS Services
  • Design, develop and build study specific eCRFs
  • System/ User acceptance testing of the study specific eCRFs
  • Release management of production version for web-based access at all study centres / sites for all study users
  • Role based training and access for site and sponsor users
  • User support for the duration of the study
  • Database maintenance, secure UK cloud hosted data storage and backup facilities
  • Database Lock and archive extract
  • Read only access to data after database lock