The Sponsorship Department
The Oscar Lambret Center’s sponsorship activities are handled by a multidisciplinary team:
- Technical/regulatory and project management missions are handled by the Pharmacovigilance/Project Management Unit
- methodology/biostatistics and data management missions are handled by the Methodology and Biostatistics Unit.
The Project Management Unit’s missions
This unit designs, implements and monitors clinical research projects coordinated by a clinician from the Oscar Lambret Center or another facility, and sponsored by the Center. It works closely with the Methodology and Biostatistics Unit and potentially the Caen Data Management Center to manage data and monitor the quality of such data.
It oversees the safety of patients enrolled in trials sponsored by the Center by autonomously monitoring the trials in accordance with regulations: registering, evaluating and reporting serious adverse events immediately (Suspected Unexpected Serious Adverse Reactions, SUSAR) or annually (Development Safety Update Reports, DSUR).
It also coordinates the organization of Data Safety Monitoring Boards (DSMB) to guarantee the benefit/risk balance of the trials sponsored.
This DCRI project management unit can also act as a national representative for foreign sponsors.
The Methodology and Biostatistics Unit’s missions
The Methodology and Biostatistics Unit has four primary missions:
- Providing methodology advice for all stages of Oscar Lambret Center’s clinical research, from design to promotion;
- Managing some of the clinical databases for studies sponsored by the Center, to achieve databases ready for statistical analysis, and offering technical support to investigators to develop databases for the studies not sponsored;
- Overseeing statistical analyses and helping to interpret them. Compiling end-of-study statistical reports and helping to prepare conference presentations and draft articles;
- Contributing to the Center's teaching and research work, which includes designing and providing courses on biostatistics and clinical cancer research.
These tasks are in response to the increase in the Center’s research activities, both in terms of studies sponsored by the Center or coordinated by a doctor at the Center, and in terms of research projects specific to each department.
The Methodology and Biostatistics Unit works in close collaboration with the other DCRI units, in particular the Project Management/Pharmacovigilance Unit, the ITT (Invitation to Tender) coordinator and the scientific assistant.