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 firstname.lastname@example.org
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
- 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
- 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