Hybrid FSP/FSO Solutions Enable Flexibility and Agility to Keep Biotech Trials On Time and On Budget

Biotech sponsors find it beneficial to use customized FSP/full-service outsourcing solutions that are better suited to their wide range of needs.

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions. In the past, these companies would most often turn to a full-service outsourcing (FSO) model to meet their needs. More and more, they are finding value in hybrid solutions that make room for services and capabilities delivered from a functional service provider (FSP) partner as well.

• With FSO, all clinical trial tasks (e.g., study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.) are outsourced to a contract research organization (CRO) partner.
• In an FSP arrangement, the CRO performs some or all of a specific function or multiple functions (e.g., clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.

Hybrid outsourcing solutions deliver flexibility to fit any clinical trial

Across the biotech industry, sponsors are opting to use a hybrid approach that combines FSP and FSO models in highly customized solutions designed to maximize the performance and efficiency of their clinical development programs. In a hybrid model, one or more FSP offerings are added to a new or existing FSO arrangement to optimize clinical trial operations or address unforeseen circumstances and changing demands. These bespoke arrangements offer flexibility in numerous ways:

• Hybrid solutions are delivered from one CRO or multiple CROs.
• Hybrid solutions are established for one study, a protocol, the entire portfolio or even the whole company.
• Hybrid solutions support any time scale and any combination of systems and standard operating procedures.

Just as no two biotech companies are alike, neither are any two hybrid solutions the same. The PPD™ clinical research business of Thermo Fisher Scientific helps clients create all manner of flexible outsourcing solutions, many of which are detailed in our recent white paper, “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.” Some of the more common use cases that have biotech sponsors turning to hybrid FSP/FSO solutions include:

• The biotech has an FSO arrangement with a CRO that doesn’t offer all the necessary capabilities, so an FSP solution is added to fill any gaps.
• The biotech has an FSO arrangement but needs to augment it through an FSP engagement with additional people and/or other resources.
• The biotech wants to mitigate and decentralize risk by spreading contracts across more than one CRO partner.
• The biotech is planning to transition from an FSO model to an FSP model and opts for hybrid delivery to ease the transition and mitigate potential interruptions during the change.
• The biotech wants more control over a critical or strategic function and augments their FSO arrangement with an FSP solution for greater control and accountability.

PPD FSP solutions embrace the biotech mindset

As a longtime provider to all types of pharmaceutical and medical device developers around the world, we know that our clients in biotech are not the same as those in any other sector of the industry. Biotech developers tend to operate under different funding models, they usually have a tighter focus on a single product, and they operate with more flexibility and agility than larger, well-established pharmaceutical manufacturers. Being nimble and adaptable is a part of these companies’ core makeup, and it’s why they need a CRO partner that delivers nimble and adaptable solutions.

PPD FSP solutions have the breadth and depth of expertise to meet the needs of any sponsor seeking to augment their capabilities. We partner with each client to design a bespoke solution, and we remain flexible and ready to shift focus to stay in sync as the sponsor evolves. Across all our FSP engagements, we promote client success by helping ensure they meet their timelines and stay within budget.

Another recent white paper, “Focus on Biotech: Harnessing FSP Engagements to Deliver On-Time, On-Budget,” details some of the ways the FSP model supports clinical development activities for biotech companies and the value that FSP engagements bring to these organizations. Typically, these companies have existing FSO arrangements that may lack necessary capabilities or resources, leading them to add an FSP engagement that rounds out their needs while enabling high levels of flexibility and agility.

For example, it’s common for biotech firms to supplement documentation/medical writing capabilities through FSP outsourcing. Throughout the approval and marketing of a new drug or therapy, the developer needs to be able to translate complex medical data into clear and compliant scientific statements, many of which are necessary for regulatory approval. For highly specialized fields like medical writing, where in-house hiring can be difficult, a trusted FSP partner can be a reliable source of top-tier talent with uncompromising quality.

With more than 25 years of experience across more than 160 countries, PPD FSP solutions deliver the hard-to-find, top-tier expertise biotech companies need to meet their timelines. Our proven proficiency across a wide range of functional areas — powered by more than 30,000 research professionals and a history of supporting nearly 300 clients worldwide — provides much-needed resource flexibility, reliability and continuity to help you stay agile. Whether you need to augment an existing FSO relationship or add FSP services to an FSO deployment from the start, PPD FSP solutions deliver everything a biotech developer needs to facilitate successful product development and accelerate the next generation of life-changing therapies.