Medical information systems

Tender description

Amadeus is a randomised, double-blinded trial that will recruit patients across 22 centres in the UK. To ensure the successful delivery of this trial we are seeking an external supplier to deliver the data management (including database development using Medidata Rave). Amadeus (sponsored by the University of Birmingham) is an investigator initiated trial which is funded by Celgene Ltd. The funding provided is contingent upon the use of vendors with a track record of partnership with Celgene for the delivery of clinical trials. The use of these vendors would enable rapid and efficient delivery of Amadeus as the University has not previously used these vendors and the long-standing relationship that Celgene has with them would enable them to provide the UoB with advice in relation to the systems. Data derived from the trial will likely be shared with Celgene and therefore familiarity of systems will be of critical importance. The Amadeus trial (sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by Celgene Ltd. The funding provided is contingent upon the use of vendors with a track record of partnership with Celgene for the delivery of clinical trials (vendor outlined below). The use of these vendors would enable rapid and efficient delivery of Amadeus as the University of Birmingham has not previously used these vendors and the long-standing relationship that Celgene has with them would enable them to provide the UoB with advice in relation the systems. Data derived from the trial will likely be shared with Celgene and therefore familiarity of systems will be of critical importance in the selection of vendors. The preferred vendor for data management meets the criteria outlined below that are essential for delivering the clinical trial. The company has a tried and trusted relationship with Celgene to deliver clinical trials in AML and has established procedures and systems in place with Celgene that would be adaptable for the Amadeus trial and would therefore bring the value of the contract down with the UoB substantially. — experience with acute myeloid leukaemia (AML) clinical trials using Azacitidine, — experience of creating/partnering with external electronic data capture (Medidata RAVE data management platform preferred) and data management using these systems, — EDC system able to integrate with external IRT system, — access to CRF library for AML, — access to Celgene CRF libraries, — user management system allowing the CRCTU trial management team to set CRCTU and site user permissions, — data transfers to CRCTU during the trial and transfer of full eCRF data to CRCTU at the end of the trial, — provide regular updates to CRCTU on eCRF completion rates, — previous partnership with Celgene, — global provider of data management and EDC systems (incl. US) to allow international trial opening.