Clinical Trials: Accelerate Onboarding in a Functional Service Partnership (FSP) Outsourcing Model

Functional service partnerships (FSPs) often involve a high volume of dedicated resources that require complex cross-functional collaboration to coordinate resources, expectations, processes and timelines between partnership providers and clinical trial sponsors.

To better manage initial intricate and time-intensive activities and enable faster start-up, PPD created the implementation lead role to streamline the resource capacity management process and create efficiencies during the critical primary stages of an FSP engagement.

Supporting the overall operations delivery lead, the implementation lead drives the infrastructure with internal stakeholders — talent acquisition, information technology (IT), finance, and legal, to name a few —to facilitate the identification, allocation, and onboarding of resources. This allows the operations delivery lead to focus on initial strategy, planning and forecasting with the customer.

As the implementation lead deals primarily with developing processes and resource allocation strategies, the role’s involvement gradually recedes as these processes become proven and successful. The operations delivery lead then takes over full responsibility of driving ongoing resource management throughout the lifecycle of the partnership.

With significant input early in the partnership, a key deliverable from the implementation lead is an implementation plan that details all resourcing strategies and objectives to ensure a clear start to the relationship.

What are the benefits of an implementation lead role in a clinical research project?

In addition to streamlining processes and efficiencies in the early stages of a partnership, the implementation lead role brings tangible value as a conduit to several specific areas as FSP partnerships are forged. The scope of the project drives the implementation lead’s key contributions, which may include areas like:

Talent acquisition: Projects large enough to warrant an implementation lead often also require talent acquisition support. The implementation lead starts this critical step in the process early — before award — to establish strong recruitment strategies that ensure full-time equivalent (FTE) capacity needs are satisfied.

IT coordination: Effective coordination of IT equipment, software and technologies is key to a smooth transition of resources into client systems. The implementation lead evaluates, prepares, and facilitates the communication with the client to drive this process.

Financial management: From the proposal stage, the implementation lead acts as the primary liaison between client resource requests and commercial finance leads responsible for project budgets. Key elements that impact budgets, such as resources, timeline and project locations, are considered and analyzed by the implementation lead in partnership with the client.

Legal: As functional service partnerships take shape; implementation leads ensure the scope and key details are communicated to the legal lead so the project agreement can be appropriately drafted and executed. Details specific to FSP contracts, like ramp up/down timelines, budget assumptions, resource management processes and notice periods are managed according to each client’s specific requirements.

Discover how PPD FSP solutions use the implementation lead to proactively plan and strategize for maximum efficiency and project readiness, here.