IT3258F - RFT to Establish a Single Supplier Framework Agreement for the Provision of a Clinical Data Management System and Associate Services for the University of Galway

This specification sets out the requirements for the purchase of a Clinical Data Management System, hereafter referred to as a (CDMS) for the Institute for Clinical Trials in Galway (ICT). The Institute for Clinical Trials provides a comprehensive end-to-end programme that supports the development and delivery of clinical trials, from concept to implementation of findings. The Institutes main Clinical Trial Units which support database development are the HRB-Clinical Research Facility (HRB-CRF) and the CORRIB Research Centre for Advanced Imaging and Core laboratory and CORRIB Research Group who are focused on operational delivery of clinical trials. Both the HRB-CRFG and CORRIB provide an integrated Data Management service. This means seamless clinical data capture, validation, monitoring, storage, processing and archiving powered by the latest clinical research management technology. The data management team provide professional management and co-ordination of clinical research data as well as implementing the latest research-based data management processes as determined by national and international clinical research management bodies. Case Report Form (CRF) development or amendment, data collection, review and discrepancy management to ensure data quality and consistency are also key functions of the data management team. The data management team works closely with the Principal Investigators, the HRB-CRFG Biostatistics team and external research centres, to devise the data requirements based upon a clinical trial protocol and manage the creation of CRFs, electronic Databases and Data Management Plans and Files for a portfolio of studies.