The Hull Health Trials Unit (HHTU) wishes to tender for the supply and implementation of an Electronic Data Capture (EDC) system to support Health Trials within the newly established Trials Unit.

See https://supplierlive.proactisp2p.com/Account/Login for full details.------ ------ HHTU is being developed in conjunction with the Hull & East Yorkshire Hospitals NHS Trust (HEY), building on a strong and seamless University-NHS partnership. Our ambition is to become a UKCRC registered unit, and this requires investment in an EDC system that will meet the required regulatory requirements for health research and enable HHTU to develop bespoke data solutions for multi-centre studies. Establishing the HHTU is a strategic goal of the University, contributing to the vision of the University to be a world leader in well-designed applied health research, and to conduct outstanding research of relevance to our local area. The University's health research is already a major strength, helping to address critical health issues in our region and beyond, with 87% of the University's research classed as 'world-leading' or 'internationally excellent'.

HHTU will work with both academic and commercial partners to collaborate on health research projects. Proposed forecasts of the HHTU portfolio of studies which will use EDC over the next 5 years are provided the section HHTU Study Profile Predictions below. These have been divided into commercial and non-commercial, and small and large studies to give an idea of the number of sites, users and patients for each. Any application for tender must clearly state the licensing and costing model including costs per study (set-up/licensing, user licenses, number of participants, data items, monthly hosting etc.) and if different for commercial and non-commercial.

What are we looking for? The University as part of the new strategic plan for IT now looks to vendors who offer an off-the-shelf commercial, configurable software solution. The EDC tool should be able to support study design, user administration, and data entry and management. As the HHTU is a new venture we need to look at scalability of the solution to support the study volume over a 5 year period, ensuring we can set-up EDC for initial studies and meet demand moving forward as an established unit.

The HHTU requires a fully validated EDC system, enabling the HHTU 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 HHTU 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.