Clinical Trials Unit Database Management System (DBMS)

Description

The University of Southampton is contracting for the supply of a Clinical Trials Unit Database Management System for one of its departments. The Clinical Trials Unit [SCTU], Faculty of Medicine, University of Southampton is a research group that coordinates national and international clinical trials, which uses a clinical trial data management system (CTDMS) for capturing and managing results data. The SCTU currently handle an average of 15 active trials at any one time, starting approximately four new trials per year. The CTU manage trials in all phases [I-IV] with the average duration of 4 years, although a number of longer term trials run for up to 10 years. The SCTU has a requirement to procure an off the shelf remote data capture [RDC] Clinical Trials database management system. The chosen solution will allow the clinical trials unit to expand on the number of active trials working with a professional, modern, fit for purpose system which requires minimal adaptation prior to roll out. A successful and timely implementation is vital to ensuring that the SCTU is able to continue with core business; to avoid a loss of income and impact on the professional reputation of SCTU, Faculty of Medicine and the University of Southampton. The University and the clinical trials unit has strict Data Protection requirements and therefore any selected solution must be able to meet the University's strict requirements in relation to data protection. This contract commenced on 5th May 2016 and was awarded under the Open procedure. The high-level evaluation criteria was based upon a 70:30 quality/cost ratio (further details can be found at IV.2.1).