FaR-RMS Trial - Clinical trial database

Tender description

The FaR-RMS trial (Sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by Cancer Research UK and Bayer AG. The funding is contingent upon having a suitably compliant clinical trial database that is active and ready for use by the end of 2021. Funding is provided to support the trial to be compliant with additional regulations. The trial used an existing clinical trial database (also sourced externally) however upon review, the existing clinical trial database is not suitable for the revised scope of the trial. Therefore, a new clinical trial database that is regulatory compliant, is able to be delivered within a tight timeline and fall within budget is required. Lot 1: The FaR-RMS trial (Sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by Cancer Research UK and Bayer AG. The funding is contingent upon having a suitably compliant clinical trial database that is active and ready for use by the end of 2021. Funding is provided to support the trial to be compliant with additional regulations. The trial used an existing clinical trial database (also sourced externally) however upon review, the existing clinical trial database is not suitable for the revised scope of the trial. Therefore, a new clinical trial database that is regulatory compliant, is able to be delivered within a tight timeline and fall within budget is required. The preferred vendor for creating a clinical trial database for this trial is Viedoc TM.Viedoc TM meets the criteria outlined below that are essential for delivering the clinical trial. The company has a track record of delivering clinical trials to registration standard with other academic organisations running clinical trials of this nature (international, paediatric oncology trials with multiple arms) and was independently recommended to the University of Birmingham. Additionally, Viedoc TM is in the process of undergoing a detailed audit of their systems with the University of Birmingham. This is an essential requirement to perform prior to the set-up of an electronic clinical trial database when required for registration standard trials. Viedoc TM have confirmed their ability to deliver the clinical trial database in 2021 and within the budget. The detailed audit of Viedoc TM has also confirmed that it is compliant with the regulations and is therefore suitable for use in the FaR-RMS trial.