Summary
We worked with a global pharmaceutical company to standardize the pharmacovigilance process in early phase clinical development.
Situation
Recognizing the increased scrutiny on pharmacovigilance in early phase clinical development as a result of changes in regulations, increased complexity of clinical trials, and the increasing frequency of accelerated approvals, a leading pharmaceutical organization proactively assessed the pharmacovigilance process followed by the different research units (RUs) in early phase clinical trials. While all the RUs followed the standard operating procedure (SOP), there was variation on how each RU applied the SOPs. This lack of uniformity reduced traceability and transparency, and increased the potential risk of non-compliance.
The client identified the need to harmonize the pharmacovigilance process followed by the different RUs by focusing on three workstreams – people, process, and systems (data/technology). The client wanted to quickly identify the best options for utilizing people, improving process, and leveraging technology.
Satori Solution
We leveraged our expertise in pharmacovigilance and project management to meet the strict timelines of this project. We quickly established a project management office (PMO) for managing the entire project. We understood that it was a complex environment with multiple stakeholders, so it was prudent to have a fair representation of all the stakeholders. We worked with our client’s leadership team to identify key stakeholders in each workstream, and developed objectives, charters and project plans for each work stream. We also organized project-wide communication and stakeholder engagement efforts including organizing and engaging project sponsors, champions, and the steering committee.
Our team enabled discussion between different workstreams with an aim to encourage exchange of ideas. We worked with the workstreams to make sure they had the resources and structure to evaluate the current situation and identify best practices and other opportunities for improvement. We helped map out the complex pharmacovigilance systems and processes to visualize workarounds and understand the unique needs of each vertical. We supported the creation of a staffing model to increase available resources and ensure the resources were redeployed with maximum impact to early phase pharmacovigilance.
We also organized and facilitated several workshops to expedite decision making.
Results
Through effective project management, we were able to devise specific, cohesive, and actionable recommendations for each workstream. We also collaborated with key stakeholders to socialize the recommendations and ensure their implementation.