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

A recent article relating to OpenClinica, with input from CDS Team Leaders as well as the RIO, ePARCA-R and CURESPONSE study teams, can be found here.

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