To understand how to best deliver timely, efficient clinical research programs, it’s important to stay ahead of the strategies shaping the industry – particularly when it comes to drug development outsourcing models.
In recent years, the market has evolved significantly with distinct shifts in clinical research organization (CRO) engagement models. One such shift is the uptick in use of functional service partnerships (FSPs) to address issues around talent shortages, maintaining successful site relationships, and increased pressure on speed to market.
PPD’s FSP solutions help biopharmaceutical and biotechnology companies meet their timelines by delivering top-tier staff who bring a problem-solving mindset and unmatched breadth and depth of therapeutic and functional experience to the clinical development services provided. In recognition of these changing market dynamics, a complimentary report is now available from PPD that explores how the shift to FSP outsourcing models helps solve some of the key challenges currently facing the industry.
How FSP Models Solve Key Industry Challenges
Speed to Market
In the post-pandemic world, there is increased pressure to expedite speed to market – with new technologies, decentralized approaches, and regulatory pathways having evolved to accommodate rapid progression of innovative compounds to global markets, as well as competitive pressures and the commercial benefits of being first to approval. To address this, the flexibility of FSP engagements is increasingly suited to scaling up during times of pressure, or to support specific known bottlenecks with FSP programs. For example, we are seeing study start-up more often outsourced as a standalone function to establish centralized processes, provide geographic coverage where it may not already exist, maximize efficiencies, and reduce overall timelines.
Talent Shortages
The demand for clinical research professionals is extremely high and many organizations across the industry compete for the same talent. As an example, within the CRA space in North America, the demand for professionals in that role is more than double the capacity available. This has led to an average increase in salaries of approximately 15%1. As need exceeds availability, sponsors cannot hire staff fast enough or do not want to assume the risk involved in increasing internal headcount. Therefore, the FSP model serves to both fulfil an immediate need and lessen risk for the drug developer.
Clinical Research Site Relationships
With available resources at a premium, sponsors are vying to keep the best investigators and sites happy so they continue supporting their clinical trials. One way to do this involves better understanding and responding to pain points for sites, particularly primary concerns such as high CRA turnover – which can be very disruptive and lead to increased workload for site staff. An FSP is now a popular way to address this pain point as sponsors can assign a monitoring team that aligns to their specific systems and processes and facilitate smooth, long-term, positive site partnerships.
In the
1 PPD Data
