Redefining CRO sourcing model terminology to optimize outsourcing strategies

Differentiating between FSO and FSP approaches can better align model definitions for CROs and sponsors.

Introduction

The market for contracted clinical service delivery models has continued to evolve and grow at the pace of a maturing global drug development business. Over more than three decades, the use of outsourcing has intensified as corporate sponsors seek greater capacity and scale, scientific and execution expertise, cost containment and operational efficiency. . Indeed, biopharma company spending on contract service delivery models is growing rapidly at 6-8% per year, much faster than the rate of sponsor company spending on in-house R&D operations and infrastructure.1.2

Underlying landscape trends driving demand growth include the growing prevalence of small businesses with very limited clinical research capacity and talent; leaner operating models for corporate sponsors; and the biopharma company’s ongoing desire to continually assess which skills provide strategic advantages that should be kept in-house or managed by external collaborators.

Provisioning models – defined in the past

Twenty years ago, “full-service outsourcing (FSO)” and “functional service provider (FSP)” were separate models and biopharmaceutical companies tended to gravitate towards one or the other.

Over time, however, the distinction between FSO and FSP has become more difficult to define. Today, corporate sponsors simultaneously use a variety of contract service delivery models to support their studies, mixing and matching a wide variety of outsourcing approaches that vary from study to study.

Partly due to the variety and combination of approaches used, today the terms FSO and FSP are often misunderstood, not only between companies, but also within companies, across functions and domains. therapies. For example, here are the definitions of FSOs in the literature:

  • “A company contracted by another company or a research center to take over parts of the conduct of a clinical trial. The company may design, manage and monitor the trial and analyze the results.“3
  • A CRO who “provides the planning and execution of a clinical study, including oversight and accountability for achieving milestones, from our centralized project management team.”4
  • “A person or organization (commercial, academic, or otherwise) engaged by Sponsor to perform one or more of a Sponsor’s trial-related tasks and functions.”5

“Full service”, for example, has largely become a catch-all phrase that has limited meaning or relevance. Many sponsors refer to their outsourcing approach as Full-Service when in fact their approach falls somewhere between FSO and FSP.

There are a number of reasons why there is so much confusion today. Many corporate sponsors are simply too big and too fragmented to consistently adhere to a single outsourcing model. Clinical projects have become so complex that they require the support of a larger and more diverse group of providers.6 And many large corporate sponsors that have formed outsourcing relationships still have significant internal development resources, creating internal competition with comparable external resources.

Ongoing legacy activity when new partnerships are formed also contributes to the problem. Clinical teams have typically established their own relationships with select service providers and resist handing over existing projects to new collaborators. Companies undergoing mergers and acquisitions, in particular, are often forced to allow inconsistent practices across organizational functions to ensure that legacy projects are completed as new approaches are introduced.

Another reason is the turnover of key senior executives who champion, oversee and implement a given sourcing strategy. Outsourcing strategies that have not been sufficiently adopted are likely to crumble when new leaders, who may have different ideas about sourcing models, take over.

Therefore, in practice, the outsourcing models currently in use reflect a wide range of permutations and combinations.

A pressing need for new terminology

The lack of distinction, misunderstanding and misuse of the terms FSO and FSP ultimately fail to provide corporate sponsors with meaningful and actionable information to inform strategic decision-making and continuous improvement. Although biopharmaceutical companies today collect a large amount of operational data to inform, predict and ultimately optimize clinical trial performance, without a clear understanding of the differentiated outsourcing models used, this data provides an insufficient, holistic understanding. and by function, the contribution and comparative value of a given product. model or combination of models.

Additionally, although the original definitions of the FSP and FSO outsourcing models have not adapted over the past two decades, the operating models of corporate sponsors have continued to evolve. As such, it is critical that we update outsourcing terminology to accurately describe the work actually performed. The best way to do this is to gather broad industry feedback and develop consensus definitions that can be easily applied to outsourcing strategies and decision making.

We propose that the underlying principle that now differentiates FSO and FSP type service permutations and combinations is the use of the CRO’s infrastructure, processes and potentially standard operating procedures (SOPs) for conducting trials. clinics. Over the past decade, sponsor companies have attempted to differentiate their outsourcing practices by type of contracted services (e.g., unit services, deliverables, results vs. FTEs) and/or or the level of responsibility assigned to the CRO. The reality is that sourcing models are being adjusted and adapted across multiple service lines as organizations continue to evolve.

Based on extensive input from the ICON Pharmaceutical Company’s community of choice partners and extensive discussions with individual corporate sponsors, the following framework (see Table 1 below) was developed to characterize the variety of models of used according to three main parameters: (1) orientation towards outsourcing; (2) infrastructure support; and (3) accountability and procurement structure.

Given their size, set-up, portfolio and core competencies, many medium and large biopharmaceutical companies operate “mixed models” and combinations of supply models at the clinical trial level. Other corporate sponsors, for example, have different sourcing approaches depending on the strategic value of the asset under development (e.g. registration/pivot in one model and late stage/post-approval in another) and domain therapeutic. Table 2 below presents, for illustrative purposes, an application of our proposed procurement model framework to better characterize the variation in approaches corporate sponsors use to leverage contracted clinical services.

Final Thoughts

We invite feedback and feedback on this proposed new taxonomy and framework. We hope that this framework will be discussed, refined and improved. Versions of this framework will ultimately serve as a more relevant and useful approach to identifying patterns, and pattern combinations, associated with higher levels of performance, efficiency, and quality.

With a lack of differentiation between FSO and FSP approaches today, it is essential for CROs and corporate sponsors to align with the definitions of the sourcing models in use. Universal definitions will ensure a common understanding between partners and across the industry regarding roles, responsibilities and accountabilities. Consistency in the descriptions we use to characterize “how we work” is also essential to establishing industry-wide recognition and acceptance of benchmarks that allow for more meaningful and reasonable comparisons of product effectiveness. one or a combination of procurement models relative to others through the life of a development project. All of this will ultimately lead to better quality work and better patient outcomes.

ICON is currently engaging with the Tufts Center for the Study of Drug Development (Tufts CSDD) – with input from and in collaboration with ICON’s biopharmaceutical company Partners of Choice (PoC) – to conduct a primary research study comparing the results clinical trial performance through the implementation of better defined and relevant procurement model strategies.

Kenneth GetzExecutive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Samir ShahPresident, Strategic Solutions, ICON

Dr Joachim LuithleSVP, Head of Clinical Development Operations, Bayer

Dr. Mark TraversVP, Head of GCTO Regions and Head Quarters Functions at Merck & Co

References

  1. Kaitin K. Outsourcing exceeds internal spending but remains tactical and reactive.Impact report: analysis and overview of critical drug development issues. March/April 2019; 21(2).
  2. Brooks K. Contract Pharma 20th Anniversary Retrospective. Pharma contract. 2019; 21(8). https://www.contractpharma.com/issues/2019-10-01/view_features/contract-pharmas-20th-anniversary-retrospective/ accessed February 4, 2020.
  3. NCI Dictionaries: Dictionary of Cancer Terms [Internet]. C2020. NIH National Cancer Institute. [Cited 2022 Jul 18]. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/contract-research-organization
  4. full-service ORC [Internet]. C2022. Aptus Clinic. [cited 2022 Jul 18]. Available at: https://aptusclinical.com/services/full-service-cro-solution/
  5. Good Clinical Practices Network [Internet]. Avistar Business Solutions. [cited 2022 Jul 18]. Available at: https://ichgcp.net/1glossary#:~:text=1.20%20Contract%20Research%20Organization%20(CRO,trial%2Drelated%20duties%20and%20functions
  6. Getz K, Smith Z, Kravet M. Protocol design and performance benchmarks by phase and by oncology and rare disease subgroups.SHOTS 2022; doi.org/10.1007/s43441-022-00438-5.