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 cds_services@imperial.ac.uk

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

The Collaborations Section is currently being updated. 

If your request falls under one of the Therapeutic areas details for the relevant email can be found on the Therapeutic Area Contact Details Page.

For commercial sponsors

Visit our dedicated website for commercial sponsors interested in working with ICTU.

Short term recruitment: Clinical Trials Manager (Casual)

An opportunity has arisen for an experienced Clinical Trial Manager to join the Imperial Clinical Trials Unit (ICTU), a member of the UK-registered Clinical Trials Network, on a casual basis.

Working autonomously and acting as a trusted partner to Chief Investigators and trial teams, you will be responsible for the successful delivery of complex multicentre clinical trials.

The role will primarily oversee two studies within the ICTU portfolio: the Phase III CARE UK trial investigating an investigational medicinal product for childhood asthma, and the Phase II FAITH trial investigating faecal microbiota transplantation in severe alcohol-related hepatitis. You will also support the set-up of additional studies and contribute to process improvements across the Unit.

The successful candidate will have experience managing multicentre CTIMPs, a strong understanding of GCP and clinical trial regulations, and a proven track record of coordinating study set-up, site management, monitoring, regulatory submissions and trial oversight.

If you are passionate about delivering high-quality clinical research and enjoy working in a collaborative and dynamic environment, we would love to hear from you.

Please see the Job Description and person specification by clicking this link:  Temporary Clinical Trials Manager opportunity