A publicly traded pharmaceutical company with a single product in late development requested the support of FHA to oversee safety in a late phase clinical trial. The role included several components:
- Providing significant education to the client company about elements of an effective Pharmacovigilance (PV) system
- Understanding/determining obligations, roles, and responsibilities for safety within the clinical trial
- Determining how each of the above were being met, both by the sponsor (client) and CRO
- Authoring a small number of standard operating procedures (SOP) to support the safety processes
We assembled a core team consisting of a senior safety physician and a senior nurse who is a clinical operations expert. An extended team was also assigned, including a non-physician PV expert and a project manager, to be included if needed to provide additional support. The team structure allowed us to address a number of different challenges that arose during the project and was considered highly cost-effective as we matched skills to needs and in the proper amounts.
Note: During the performance of a clinical trial, many situations arise that are outside the scope of CRO agreements and sponsor job responsibilities. Frequently, despite a deep commitment from all sides, there isn’t enough capacity to get everything done. Part of our value to clients is to simply ensure that things are taken care of, avoiding downstream consequences.