Translational Research Group
We have a proven track record collaborating with industry and academia, having demonstrated our ability to conduct trials to International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) standards and to meet firm deadlines. Some of our key strengths include:
The DTU has an in-house, DPA compliant, electronic recruitment register that holds records from volunteers who have consented to be contacted about future TRG research projects. Automated, targeted mail shot facilities allow us to streamline contact with potential trial participants and greatly reduce recruitment lead times. Our experienced research staff and purpose built facilities also mean that we are well placed to not only recruit participants, but crucially to also retain them to the end of the study.
A major reason for delays in reaching the first patient first visit (FPFV) in a trial is securing the necessary regulatory approvals. The TRG has extensive experience in both investigational medicinal product (IMP) and medical device submissions with an excellent track record in obtaining approvals and sound relationships with local R&D offices that ensure local approvals are efficiently managed.
Patient materials are thoroughly reviewed by the DTU Communications Manager and the Thames Valley Diabetes Research Network Patient Panel prior to circulation. This helps to ensure we present studies in a readily comprehensible form. Engaging with patients at the study design stage not only provides constructive feedback, but also strengthens our applications for ethical approval.
The DTU values the synergistic relationship between academia and industry and has a history of successful collaborations. Utilising a UK-wide, commercially endorsed, model clinical trial agreement and a transparent costing approach, we can provide a smooth and rapid contract negotiation process, leading to efficient study initiation timelines.
An agreed 'division of responsibilities' is negotiated from the outset, to draw on the respective strengths and interests of both partners, and this forms a vital component of the final clinical trial agreement.
All TRG trials are allocated a Project Manager who ensures that realistic timelines for key deliverables are agreed and communicated with all stakeholders and that the project is managed professionally and effectively throughout. All projects are assigned a dedicated project team who communicate frequently with the study sponsor via documented meetings or teleconferences.