Our services when delivering a grant application include:
- Assisting with grant applications and costings
- Helping to identify appropriate clinical trial teams
- Developing timelines and plans.
Services once funding has been awarded include:
- Developing timelines and plans to assist with the time-to-target agenda (including the ‘70-day clock’)
- Coordinating the development and review of essential documentation
- Preparing submissions to ethical and regulatory bodies
- Regular production of progress reports to ethics committees, regulatory authorities and funding bodies
- Budget management (and, for Guy’s and St Thomas’ budgets, cost centre set-up)
- Acting as a point of contact for sites participating in the clinical trial and developing effective and regular communication with key personnel for multi-centre trials
- Being a key liaison with the clinical trial sponsor
- Assisting central laboratories in setting up their processes in order to receive and analyse samples from clinical trial patients
- Liaising with the supplier(s) of investigational medicinal product (IMP)
- Working with the database developer, data manager and trial statistician to ensure systems and documentation are in place for data capture
- Being a source of knowledge and advice on the clinical trial and on wider clinical research legislation and governance.