January/February 2024 • PharmaTimes Magazine • 16-17
// CLINICAL TRIALS //
Super models
How to realise the full potential of functional service provider roles
Today’s clinical trial environment is changing how life sciences companies outsource core research tasks.
Sponsors are facing increasing costs, continued patient recruitment challenges, and huge changes in how clinical trial data is collected and monitored.
This is driving demand for more flexible approaches that deliver the ability to engage expert services when and where they are needed.
Sponsors are increasingly complementing the traditional full-service contract research organisation (CRO) model, for example, with the functional service provider (FSP) approach. In 2020, large biopharma companies’ use of FSP was growing at more than 13% a year.
‘Well-functioning FSPs are a natural extension of the sponsor, harnessing external expertise and encouraging long-term partnerships’
It is a model that allows clients to engage experts in biostatistics or clinical monitoring, for example, who can work within their own systems and standard operating procedures (SOPs).
It also creates opportunities for professionals, as it combines the security of a long-term position with the opportunity to work with a variety of clients, learning new systems and continuously upskilling.
Yet, despite the abundant opportunities, misconceptions around the approach and the roles within it remain. In this article, we tackle some of the myths, and highlight the opportunities FSP offers the life sciences industry at large, as well as those who work within it.
Skill set surge
FSP allows sponsors to outsource specific functions, whether that’s biostatistics or clinical monitoring management, to external partners.
This approach, which differs from the end-to-end support provided by traditional full-service CROs, has a number of benefits in today’s research landscape:
- Among ever increasingly complex trial designs and a spiralling number of datapoints, ‘big pharma’ companies are bringing much research activity back in house. This allows them to retain control and regulatory oversight, but can also leave gaps in expertise. The FSP model allows them to recruit only the skills they need, while keeping a tight grip on their studies
- Smaller pharma and biotech companies, which currently hold a significant proportion of advanced molecules in development, do not necessarily have the expertise or connections needed to drive their research programmes. They will naturally look to outsource specific functions to fill the gaps.
FSP gives sponsors big or small access to the right people, at the right time. Data science, for example, is a rapidly growing discipline, and life sciences is just one of the sectors vying for candidates.
In an environment where biopharmaceutical companies are under increasing pressure to improve productivity and efficiency, FSPs offer a flexible approach. Resources can be redistributed across geographic areas or within a therapeutic area programme based on sponsor priorities. FSPs also offer site sponsors access to an expanded talent pool of subject experts with skill sets they may not have access to in-house.
Misconceptions minefield
Despite the benefits of the FSP, a number of unfounded misconceptions remain. Here are a few examples of myths in contrast to realities.
Myth: FSP is nothing more than a staff augmentation model.
Reality: Well-functioning FSPs are a natural extension of the sponsor, harnessing external expertise and encouraging long-term partnerships while still maintaining clear definitions of each organisation’s responsibilities.
Myth: FSPs are simply a cost-saving device.
Reality: While it is true that the approach can lower developer costs by reducing redundant activities, sponsors can also expect to access domain expertise from their FSP providers.
‘Quality’ and ‘innovation’ now feature as often as ‘costs’ in requests for information. Furthermore, the emergence of artificial intelligence (AI) and machine learning (ML) into study conduct is further increasing demand for the level of expertise that specialist providers offer.
Myth: FSP staff complete boring, repetitive tasks and experience a lack of variety.
Reality: FSP experts are outsourced, as part of a client team, to different big pharma organisations giving them the opportunity to learn new systems, access new data and continuously upskill – all while benefiting from the support and job security of working for an FSP provider.
Know-how
Recruitment by a specialist provider allows candidates to work with the leaders in their field. FSPs attract talented experts because of their reputation, their investment focus and their extensive networks.
Management teams at FSPs also typically consist of technical experts with deep knowledge of their field.
It is, however, vital everyone working in an FSP feels able to access the knowledge and support of their wider organisation. FSP staff should feel valued, not just in terms of legal contracts but also through clear communication and support systems.
A project led by Phastar has been exploring a cross-functional, client-agnostic approach to better support people in FSP roles.
This has led to progress in five key areas:
- A cross-functional team dedicated to FSP support
- Improving and aligning guidance for people moving to FSP roles
- Technical support for any client, grade, or role
- Ensuring processes are suitable for all roles
- New initiatives supporting well-being
This kind of support is vital to boost staff retention in FSPs, which in turn is crucial for successful outcomes and high client satisfaction
Final analysis
Sponsors need to build relationships with providers who can help them succeed in a rapidly evolving marketplace.
They need to assess where the best domain knowledge resides and who offers expertise in emerging techniques and technologies.
The role of FSPs and their contribution to sponsors is adapting. For example, it is no longer just about technical project contribution as a team or singularly.
FSPs can provide sponsor oversight support and utilise aspects of business operations data to maintain clinical development and reporting.
We also, however, need to ensure FSPs continue to deploy the highest-quality candidates to ensure we can meet these needs.
To do this we must focus on improved support for current FSP staff and raising awareness of the huge opportunities on offer to new recruits.
Elisa Mansfield is Vice President, FSP Biometrics at Phastar.
Go to phastar.com
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