How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

Explore how FSP solutions enable biotech companies to efficiently and cost-effectively complete key functions.

The biotech industry is a dynamic sector, rapidly evolving and poised for continued growth. Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success.

Because biotech companies need to remain flexible and agile – while remaining on time and on budget – they are harnessing innovations to navigate unexpected drug development challenges and leveraging strategies to fill gaps in resources and expertise. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

FSP solutions are being more frequently utilized by biotech companies

Biotech companies employ contract research organizations (CROs) to handle trial-related functions and services, often delivered through a full-service outsourcing (FSO) model, an FSP model or a mixed model combining both. FSP outsourcing is growing faster than FSO. And in a recent survey from the PPD™ clinical research business of Thermo Fisher Scientific, 34% of participants say they prefer hybrid FSP/FSO outsourcing for clinical development (up from 22% in 2023).

• FSO arrangements: All clinical trial tasks (study startup, data management, clinical monitoring, pharmacovigilance and regulatory affairs, for example) are outsourced to the CRO on a study or protocol basis.
• FSP models: The CRO handles specific functions (e.g., clinical operations, pharmacovigilance, regulatory) across various medicinal products, a portfolio of studies or the entire company.
• Mixed models: FSP and FSO models are combined into customized, cost-effective, efficient and streamlined solutions to best meet the sponsor’s needs. Using this approach, CROs can integrate single or multiple FSP services into an existing FSO arrangement or from the outset.

The need for FSP support across different functions may arise because the sponsor has chosen to focus its core workforce on critical internal competencies, leaving other in-house functions undeveloped. Alternatively, rapid growth may have stretched personnel and resources thin, necessitating a quick ramp-up as the asset develops. Whatever the reason, a tailored FSP solution can be designed to meet the sponsor’s unique needs and align with the fast-paced, agile nature of a biotech company.

FSP solutions are ideal for biotech companies that need to efficiently and cost-effectively complete key functions, including:

• Study startup and site support: Launching sites on schedule is crucial for meeting clinical trial timelines, and an FSP partner helps biotech organizations achieve this milestone with support for site identification, streamlining study startup processes, and administrative assistance that alleviates the burden on staff.
• Pharmacovigilance (PV): A premier FSP PV partner provides expertise to monitor global regulations, analyze and interpret them in the context of a biotech’s specific needs, communicate regulatory requirements, and implement solutions to support the sponsor’s internal capabilities.
• Documentation/medical writing: Regional regulatory agencies (such as the U.S. Food and Drug Administration and the European Medicines Agency) impose strict formatting requirements that have a high risk of error, which makes this highly specialized service an ideal function to outsource to an experienced FSP partner.
• Data management: As trial complexity and volume continue to increase, an FSP partner provides the necessary technology, processes and expertise to quickly and efficiently consolidate, validate and review disparate data sources, safeguarding data integrity.
• Biostatistics and programming: Managing, standardizing and analyzing collected data is another crucial success factor and an area where an FSP partner provides the technical skills and infrastructure required to stay agile as demand and workload fluctuates throughout the trial.
• Regulatory affairs (RA): As the regulatory landscape continues to evolve, influenced by medical, scientific, technological and political elements, biotech companies can benefit from an FSP partner capable of delivering scalable RA capabilities to navigate ever evolving regulations.

A medical writing case study

As an example of the value that PPD™ Functional Service Partnership (FSP) solutions bring to biotech developers, here is a look at how we delivered the best possible outcomes as the preferred medical writing partner for a small company that develops and commercializes rare disease therapeutics.

Since 2022, our PPD FSP Medical Writing solutions team has been working with a small development-stage company, initially to write a protocol for one of their studies, where the client could evaluate our capabilities and performance. Our PPD FSP Medical Writing solutions team worked diligently to build trust by:

• Showcasing our ability to structure the sponsor’s Phase I study for success by incorporating SME-level expertise
• Providing deep document and template knowledge, leading to a thorough template analysis and strategic mitigation of risks in the sponsor’s protocols
• Transitioning to a consultancy role, after becoming familiar with the client and their needs, to provide advice and leadership on industry trends, including the impact of the EU Clinical Trial Regulation (CTR) on the protocol

The partnership enabled the client to experience our integrity in action. They were particularly impressed with our transparent and responsive invoicing, which ultimately reduced their expected charges when some tasks were less complex or time-consuming than initially anticipated.

By establishing ourselves as a trusted partner, our PPD FSP Medical Writing solutions team went from supporting one pilot protocol to 20 completed or ongoing deliverables within a two-year period.

PPD FSP solutions teams embrace the biotech mindset

Most small biotech companies are focused on a single compound, which requires a more nurturing approach across the development pathway. Our PPD FSP solutions team understands this mindset and helps our biotech clients succeed by providing targeted, focused and nurtured services across all functions and phases of drug development.

Backed by more than 25 years supporting clinical and marketed products for nearly 300 clients, we know what it takes to build nimble, agile, bespoke solutions tailored to the unique needs of each client. Our global solutions provide the breadth and depth of therapeutic and functional expertise needed to provide biotech companies with resource flexibility, reliability and continuity to meet their timelines and accelerate the next generation of life-changing therapies.