Methodological coordination
Coordination of clinical study design, with contacts to Clinical Research experts to support and challenge strategy upstream and during protocol design (study design, regulatory constraints, operational feasibility, etc.).
Pharmacy and paramedical advice
Contacts with medical and paramedical experts to provide support and advice on the use of drugs and medical devices.
Writing expertise
- Assistance in writing the synopsis and/or study protocol by clinical research experts.
- Help advice on drafting the technical document of the medical product(s) (IMPD / drug file / instructions for use).
Budget
Support for project budget evaluation by providing cost estimates for staff time, hospital overheads and operating costs, based on the costs applied by an academic sponsor. These estimates will help you when responding to calls for projects for fund-raising.
Networking
- Help in identifying GR / PSCC technology platforms able to perform the analytical techniques involved in the study, and put them in touch with each other.
- Support for the identification of expert investigating sites according to the indications explored and the medical product(s).
Documents review
Provide strong feedback by experts on the already written study documents (synopsis, protocol, IMPD, operating manuals, IB, …).
Operational advice
Advice on the operational feasibility of the clinical project to highlight the potential logistics issues to adjust for avoiding any protocol deviation and to enhance patient compliance
