Clinical Trials Unit Database Management System

Tender description

The University has a procurement opportunity for the supply of a Clinical Trials Unit Database Management System for one of its departments. This tender invites you to submit your response for a solution which is able to conform to the following specifications: 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. It is anticipated that the service will be in place for January 2016. The University and the clinical trials unit has strict Data Protection requirements and therefore any selected solution must be able to meet the mandatory requirements related to data protection that are documented in the technical and functional requirements spreadsheet and the Data Management Policy as per Annex 1. All responses will be reviewed for compliance against mandatory requirements during the evaluation process, and Tenderers will be requested to perform scenario demonstrations to be scored by the evaluation team in addition to the detail requested within the written submission. The University will contact Tenderers as soon as possible to arrange the visit and discuss tenderer's needs for undertaking the demonstration. Under no circumstances whatsoever will the University of Southampton be liable for or pay any expenses or costs which may be incurred (whether directly or indirectly) by the tenderer in the preparation or submission of their tender proposal. The University of Southampton is not bound to accept the lowest offer or any tender in full or in part. In evaluating the tender, the University will seek the most economically advantageous offers in terms of the criteria listed below: Mandatory requirements Pass/fail Supplementary information 10 % Functional requirements 30 % Non-functional requirements 20 % Live demonstration 10 % Pricing 30% Bidders are advised that the deadline for clar...