Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

Today’s clinical trials increasingly embrace FSP models as the best solution for securing high-level talent while remaining flexible and cost-effective.

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area. A recent white paper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years, moving from capabilities that were previously built up and maintained in-house, to the multiple outsourcing models available today.

Clinical operations encompass a range of important functions, including clinical monitoring, site management, clinical oversight, support services and site engagement. To support these functions, PPD™ Functional Service Partnership (FSP) Clinical Operations solutions harness the full range of innovative technologies, applying extensive skill and expertise to empower our customers to bring therapies to market quickly and within budget. For our clients, the ability to outsource these capabilities is a marked improvement compared to hiring, training and maintaining a large workforce to fulfill every aspect of clinical operations — a feat made even more complicated by workloads that can fluctuate widely depending on the number of products under development.

For clinical operations, FSP takes the lead among outsourcing models

Many factors affect the ability to drive a clinical development project to successful completion. The following three common approaches — alone or in combination — have historically provided a wide range of capabilities from which any project can find an optimal fit:

• Direct hires: This path provides the most control and stability, but it is typically the least flexible option and therefore may not deliver the resiliency needed in cases where work volumes are expected to fluctuate.
• Contracting agencies and independent contractors: A contract workforce solution is also not as flexible and is best suited to meeting short-term or part-time requirements. It is also important to keep in mind that using contract workers can increase co-employment and misclassification risks.
• Contract research organizations (CROs)/FSP partners: Staffing from CROs through FSP partnerships reduces legal risks, shifts management and training burden to vendors, and provides flexibility during ramp-up and ramp-down phases.

In a recent survey of drug developers about their outsourcing practices, 41% of respondents increased their use of FSP engagements compared to two years ago. For the most part, the industry is looking to these FSP partnerships and hybrid FSP/FSO (full-service outsourcing) approaches for their ability to more effectively implement new and innovative strategies and keep projects on schedule. Overall, the survey shows that trial sponsors count on these staffing models to enable high levels of transformation, efficiency and flexibility — all in service of meeting critical timelines.

For drug developers, the FSP model has earned its spot at the top by proving to be a reliable means of securing top-level talent while also enabling rapid expansion or reduction as clinical development needs ebb and flow. The FSP approach offers the flexibility to complement a sponsor’s existing capabilities with dedicated functional expertise when and where it is needed — encompassing all the expertise, services, technologies and processes that a developer might require. This high level of flexibility is often key to addressing the full range of challenges on the way to successful development and is a critical factor in meeting budgets and timelines.

For clinical operations roles, the provision of skilled staff, particularly in the form of clinical research associates (CRAs), is a major contributor to a study’s success. PPD FSP Clinical Operations solutions are distinguished by the quality of our CRAs, clinical trial coordinators (CTCs) and other clinical operations staff. In FSP partnerships, these highly valued experts provide end-to-end monitoring services and are often involved throughout the study life cycle, from qualification to close out — all of which is only made possible through detailed training and cross-training.

Another critical capability of a CRO partner is to alleviate the quality control burden from the sponsor. We accomplish this through several avenues, such as providing a dedicated functional manager (FM) role, delivering expert FSP resources at the country level in areas all around the globe, and even deploying embedded managers who sit at the country level and form part of the sponsor’s extended team.

Often our clients are keen to retain oversight and control, even as they take advantage of FSP models. In many cases, higher levels of sponsor oversight are even required by regulation. Rather than outsourcing operations for entire studies, our FSP model enables drug developers to fill specific functions or roles and still closely maintain control over project delivery and costs.

For a prospective FSP clinical operations partner, flexibility is key

Staffing a clinical development project with a highly skilled workforce first requires a strategic assessment of internal talent to ascertain how best to supplement in-house capabilities while maintaining focus on maximizing quality and efficiency. When making decisions on whether to rely on direct hires or to outsource services or roles, vendors must balance expertise, cost, risk, reliability and continuity.

Given these considerations, it’s clear why FSP models have risen to the top of the evolutionary ladder — they are often best suited to deliver the high degree of flexibility necessary to support on-time, on-budget delivery. Our 25 years of high-quality FSP support and expertise mean you can count on PPD FSP Clinical Operations solutions to deliver the breadth and depth of expertise you need to meet your timelines. And our comprehensive solutions are staffed by problem-solving professionals and powered by flexible delivery models to ensure timely, end-to-end execution of every project.

Our ability to attract, train, develop and retain talent also delivers high levels of engagement while maintaining turnover rates well below industry norms. Over the years, we have honed our bespoke recruitment strategies that combine the advantages of traditional full-service outsourcing and FSP resourcing by drawing from an internal pool of staff and using proactive, external recruiting — all with a focus on staff quality and continuity.

Whether you require specialized skills to complement existing expertise or an outsourced solution to perform all aspects of clinical monitoring and site management, we deliver customized clinical operations solutions and the resource flexibility, reliability and continuity you need to keep every project on schedule. Across more than 160 countries, PPD FSP Clinical Operations solutions help biotech and biopharmaceutical companies meet their timelines by delivering the best of the best: hard-to-find, top-tier staff who bring a customer-first, problem-solving mindset to the clinical development services we provide.