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 Interactive Response Technology (IRT) for patient randomisation, blinding, unblinding and pack management services. 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 (vendors 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 Interactive Response Technology (IRT) 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 of seamless integration with external electronic data capture (EDC) systems, such as Medidata RAVE, with frequent data synchronisation, such as with each patient randomisation, — previous partnership with Celgene, — familiarity with Celgene IMP management/distribution systems, — fast system development (within 6 weeks) due to familiarity with Celgene processes, — experience with acute myeloid leukaemia (AML) clinical trials using Azacitidine, — inventory management, — provide randomisation service that can cope with mid-study changes, such as addition of a randomisation arm or change in randomisation ratio between arms, — configurable design allowing rapid change requests to be implemented, — provide both real-time access to reports, — real-time alerts and notifications to end users, — product return management, — to provide user acceptance testing before system release — able to demonstrate minimal user acceptance testing findings and timely delivery of the system, — 24/7/365 helpline support, — 100 % focus on IRT as the only product.