independent Chief Safety Officer (iCSO)
A publicly traded pharmaceutical company with a single product in late development requested the support of Fiore Healthcare Advisors 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 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 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.
Step 1: We performed an analysis of sponsor and CRO obligations for the recently initiated clinical trial. We built a model that allowed us to understand how obligations were being met by both parties and allowed us to identify gaps in both sides.
Step 2: We next developed a set of recommendations that included actions to be initiated by the Sponsor as well as actions that we would initiate on behalf of the Sponsor. We also worked with the CRO to ensure that their obligations were met. We developed standard operating procedures (SOP) that supported all Sponsor actions.
Step 3: Following the brief planning step we rolled up our sleeves and worked alongside the Sponsor to prioritize and tackle the set of recommendations. Actions were taken to ensure the safety of patients in the clinical trial as well as ensure data integrity.