Quality Management System

Building an Effective Safety System with an Outsourced Safety Partner

FHA was asked to assist a publicly traded development stage pharmaceutical company in setting up a safety system that would support late-stage clinical trials as well as postmarketing for their product, after approval.  We developed a strategy that included the following elements:

  • An overall development of the safety system
  • Determination of areas to build internally vs. those to ‘buy’ (outsource)
  • For outsourced elements, approach toward sourcing (including vendor identification, assessment)
  • Establishment of governance structure to ensure proper oversight of outsourced activities
Quality Management Image

Assemble the team and gather information. We assembled a hybrid team consisting of a PV expert, a PV outsourcing expert, and a business project manager to work alongside a client team leader and subject matter experts from the client company.  The executive sponsor was the functional head.  The team was designed to maximally leverage our expertise in PV sourcing and minimize distraction of the client project team members.

Determine requirements and select the vendor.  Based upon the discussions in Step 1, we prepared a benefit risk analysis for different components of the PV system to determine which to outsource and which to build. Items such as scale, complexity, product knowledge requirement, etc. were considered. This led to a recommendation that was agreed with the client and served as the basis for a request for proposal (RFP).  The RFP was sent to a group of providers that we selected based upon our industry knowledge.  We conducted the vendor assessment and guided the selection of the network of providers that would meet the client needs.

Onboard vendor and transfer data. Following selection of the vendors that would be best able to support the client, the next step was to develop and execute an onboarding and transition plan.  These plans are always focused on ensuring business continuity and minimizing risk during the transition period. The plans are a bit complex with data migration elements, transfer of product knowledge, and process development components.

Establishing governance.  FHA designed a governance structure that would exist post go-live of the vendor network.  This is an essential element of any vendor/partner relationship because tracking the performance is a critical element of success of any outsourced relationship.  We work to identify the appropriate metrics and develop communication strategies, escalation strategies, gain sharing (penalties) and risk sharing elements and project dashboards.