Dedicated Roles Keep FSP Projects on Schedule

For drug developers, strategically selecting the right outsourcing model and dedicated roles can help maximize quality, financial and operational efficiencies, and achievement of their goals.

In recent years, biotech and biopharmaceutical companies have markedly increased their use of outsourcing, with functional service provider (FSP) partnerships and full-service outsourcing (FSO) models leading in popularity. According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models.

While the FSP model is growing in popularity and serves a critical role in pharmaceutical development, getting the most out of this model requires dedicated roles to drive implementation, communications and planning. The FSP partner is responsible for critical elements such as fast and efficient startup of the engagement; increased agility and flexibility, working within the client’s standard operating procedures (SOPs), the provider’s own SOPs or a mix of the two; and ongoing, high-touch communications. As such, it’s important that they provide the right model for success — and have a record to prove their capabilities.

Dedicated Roles Ensure Commitment to On-time Delivery and Provide Meaningful Support

Among the ways that PPD® FSP solutions stand apart in this competitive field is through two dedicated roles that coordinate key functions and direct teams of research professionals and partners to accelerate startup and deliver services on schedule. These two roles are known as operations delivery lead (ODL) and implementation lead (IL).

Operations Delivery Lead

The ODL is the single point of contact for a partnership, responsive to client needs and promoting consistent collaboration across the life span of a project/partnership. The ODL is laser-focused on oversight and strategic planning and delivers proactive, high-touch communications that ensure stability and support on-time, on-budget delivery. To accomplish this, the ODL works closely with the client to understand resourcing capabilities and capacity management — as well as the client’s culture and phenotypes — to ensure the best personnel are brought on board and the partnership is set up for success. This not only contributes to favorable outcomes in the long run, but also supports more accurate budgeting throughout complex, often years-long relationships.

The ODL also drives the system selection process and all-important user training. Many clients need their resources to adhere to their own SOPs, which requires synchronization between client training protocols and internal resource management. By fostering a collaborative approach that respects the client’s training standards, an ODL ensures resource preparedness, which in turn drives overall program success.

Implementation Lead

To support the ODL, the IL oversees the complex infrastructure of setting up an FSP partnership, including resourcing from the integrated pool of talent, information technology (IT), finance and legal, among others. This typically begins before the project is even awarded, when the IL starts to clarify project needs and develop a timely implementation plan. The IL helps reduce the client burden of implementing a partnership by taking on the heavy lifting, so the client can focus on their key deliverables and corporate goals. Each plan focuses on internal workstreams to identify and allocate the right resources at the right time, in the right geographies, to launch projects on schedule.

As the IL identifies, allocates and onboards resources, the ODL focuses on operationalizing the partnership through initial strategizing, planning and forecasting with the client. By sharing the load across ODL and IL roles, PPD FSP solutions meet client needs and drive project delivery excellence, every time. Together, the IL and ODL deliver proactive, regular communication and planning that focus on program oversight, optimization, financial oversight and key performance indicators (KPIs).

As biotech and biopharma companies seek out the best solutions in increasingly competitive talent markets – and adapt to new demands, priorities and challenges – it’s important to remember that not all FSP/FSO providers are alike. Our clients have come to rely on the ODL and IL roles for their ability to quickly identify and allocate the right resources from the breadth and depth of the PPD FSP solutions team’s expertise to launch projects quickly and to meet key timelines.