Successfully Managing Change in Your Pharmacovigilance System

Alyce McDonald, director of pharmacovigilance, and David Hillman, senior director of integrated safety services, write about effective planning and transitioning of pharmacovigilance from an insourced model or to another vendor.

As coined by an ancient Greek philosopher, one constant in life is change. In the world of pharmacovigilance (PV), the need for change comes from both the outside world (e.g., changing regulations), as well as closer to home (e.g., new products, technology upgrades, mergers and acquisitions, and outsourcing initiatives).

Managing change within a highly compliance-sensitive area can be a daunting prospect for even the most seasoned PV professional, but as an established and experienced vendor, the PPD™ clinical research business of Thermo Fisher Scientific is here to help.

On an almost weekly basis, we establish relationships with clients who are new to PV outsourcing, or who have taken the bold step of transitioning work to a new PV vendor. We also routinely help our established partners navigate change in all its guises.

Successful vendor relationships have many components, but one of the key factors is effective change management. Transparency, upfront goals, adoption of common quality and project risk management strategies, and milestone tracking are all vital in establishing and maintaining a strong partnership.

Those responsible for PV within a clinical trial sponsor or marketing authorization holder (MAH) may be understandably wary of the risks of transferring to an outsourced model, transitioning to a new vendor or acquiring new products. Lack of transition control and appropriate oversight can all too easily lead to negative implications for regulatory compliance, efficiency and cost. Regulatory authorities also rightly expect that high-quality standards are set for outsourced work, and sponsors/MAHs are obligated to continually evaluate vendor performance in relation to outsourced deliverables.

When taking over ongoing PV activities from an insourced model or outgoing vendor, we recommend a standard transition plan that defines key items required for meeting deliverables, which helps to ensure a seamless transfer. Plans are divided into the following phases:

• Implementation
  • Activities that have to be completed prior to the starting transition of responsibilities
• Transition and hypercare
  • Transition of responsibilities between parties
  • Extra vigilance in the period during and immediately following completion of transition “hypercare,” during which metrics should be frequently monitored and ad hoc troubleshooting meetings convened
• Steady state
  • Resumption of “business as usual”
  • Routine governance oversight

We recommend keeping in mind the following critical steps when transitioning PV activities between responsible parties:

• Setting expectations: The sponsor/MAH must set the tone for the transition; articulating mutual respect between the transitioning parties, setting clear expectations and defining measurable outcomes are all key to a successful outcome.
• Detailed planning: Once a transition strategy is decided upon, the plan becomes as important as the decision itself.
• Informing and managing the outgoing responsible party: Whether transitioning from an insourced model or another vendor, keeping the outgoing party in the communication loop until transition activities are complete is an important ingredient in continuity, avoiding gaps and maintaining good relationships.
• Robust project leadership: Clear communication among applicable leaders will make for a smooth transition. Additionally, allowing the new PV vendor appropriate autonomy and placing trust in the leadership to drive the transition while simultaneously keeping the sponsor/MAH and any outgoing parties apprised will help ensure forward momentum and the achieving of milestone targets.

• Oversight meetings and knowledge transfer: A defined kickoff meeting between the incoming vendor and sponsor/MAH is an important step in determining the project’s operational strategy, roles and responsibilities, communication, and transition strategy. Measures should be taken to ensure applicable product and process knowledge is transferred to the incoming vendor so all planning can be finalized.
• Continued professionalism and sensitivity of remaining work with the outgoing responsible party: Gaps in the knowledge for the incoming vendor will need to be filled through close collaboration with the outgoing responsible party; this relationship is critical to the success of the transition.
• Communication with other functions and business partners: Building relationships and communication pathways with other relevant functions (e.g., medical information, medical affairs, regulatory affairs, quality assurance, clinical management, etc.) and third-party business partners are also critical.
• Timelines: Understanding dependencies, where a timeline is in jeopardy and where there is an opportunity to make up time will help keep the project on goal for meeting milestones.
• Transfer of obligations: Once all information is shared between the outgoing responsible party and the incoming vendor to the satisfaction of all parties, the transfer of obligations can be considered complete.

In summary, pivotal to the success of any change are the following:

• Detailed planning
• Effective communication
• Robust oversight underpinned by a formal governance plan, throughout both the transition and hypercare periods, and onward into steady state

When you are transitioning PV work to the PPD clinical research business of Thermo Fisher Scientific, our focus will be on supporting your ongoing regulatory compliance throughout and beyond the change process.