The dynamic nature of the biotech industry requires operational flexibility in clinical development. One primary way biotech achieves this adaptive environment is by outsourcing at least some of its clinical development functions. In the past, they would most often turn to a full-service outsourcing (FSO) model to meet their needs. However, they are increasingly 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. 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. 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.
A recent white paper, “Focus on Biotech: Harnessing FSP Engagements to Deliver On-Time, On-Budget,” also 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.
PPD FSP solutions, part of the PPD™ clinical research business of Thermo Fisher Scientific, helps clients create all manner of flexible outsourcing solutions, many of which are detailed in “Establishing a Bespoke Outsourcing Arrangement with Hybrid FSP/FSO Partnerships.”
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.