Provision of a Hosted Clinical Data Management System (CDMS) (1)

Exeter Clinical Trials Unit (ExeCTU) is a UKCRC registered Clinical Trials Unit, housed within the University of Exeter Medical School and tasked to design, conduct, analyse and publish clinical trials and other well-designed studies. As part of our registration, the need to expand resourcing within trial design and conduct had been identified, specifically within the CTU Data team by acquiring a commercial EDC tool. This will free up developer time to work on more bespoke aspects of a trial or study data systems, and better enable the wider CTU teams to assist the data team.The Clinical Trials Unit requires a fully validated, hosted EDC system, enabling the CTU data & admin teams to design and set up custom Case Report Forms within the system for multiple trials or studies, such that remote trial teams can log in securely to record data against these forms in the context of study/trial participants and/or time points in a consistent and reliable way. The system offering should include training for the CTU data team in terms of configuring the system and designing eCRFs, some end-user training documentation for distribution upon trial/study setup, and support with any technical issues that may arise, along with an agreed plan for hosting business continuity including system uptime targets and backup schedules.