The pros and cons of FSP and Full-Service
Functional Service Provision (FSP) and Full- Service outsourcing models have been hotly debated topics over the past decade. Of course, both have their places in the market however market share shifts between the two have certainly been observed. As service providers continue to match their offerings with customers' wishes, hybrid models of FSP and Full-Service have emerged on the market.
The pros and cons of each model are well worn. Those who advocate the Full-Service approach often note the ‘one-stop-shop’ benefit - the simplified contractual arrangement, the integrated team, alongside the potential for cost savings both in efficiency and increased bargaining power, particularly if a sponsor awards several programs of studies to a single provider. Supporters of FSP often point to access to specialist providers, similar cost savings from efficiencies, flexibility on team size and the ‘plug-and-play’ nature of functional contracts.
The downsides of each tend to be the flipsides of the list of the advantages above, for one-stop-shop read generalist vs. specialist support; for specialist providers, read the need for staff to complete repetitive tasking.
To a degree, the various models shape the fabric of the companies offering them. Specialist companies attract talented technical staff because of their reputation within their field alongside their focus on investment. Experienced in house recruiters identify strong candidates more readily because they become experts in the specialism. They have extensive networks, often stemming from the company’s management team – which itself often includes technical experts with deep expertise. It is not hard to see why such businesses become function-centric and why sponsors consider FSP not only when looking for volume provision, but also when they are dealing with technically difficult problems.
On the other hand, Full-Service companies offer a different option for candidates. These companies would typically be larger than their specialist FSP counterparts. The largest contract research organisations (CROs) are all Full-Service but may also offer FSP propositions. For some, working in a big company can be very attractive. Once established within a large company, a candidate can seek out more varied opportunities—perhaps having a career change within the same employer. Staff in FS companies can have more visibility to the clinical trials process going on around them—they may feel more part of the overall team. The larger CROs deliver more of the “mega trials”, which can drive excitement within the working environment. For specific roles, such as project management, the remit is wider than typically seen in the specialist setting. Sponsors may be drawn to Full-Service CRO’s when outsourcing large programmes of work or larger individual studies.
Making the Choice: FSP, Full-Service, (or Hybrid)?
Sponsor companies have seen successes with both approaches, with neither showing any sign of disappearing. However, if you are new to outsourcing, or are coming across your first big programme of work, what are the considerations that shape your decision between the two and is hybrid the compromise that will deliver the optimum outsourcing strategy?
It is when examining the detail that the focus on the pros and cons of a methodology is strongest. Where the work product involves a high volume of functional expertise, FSP can deliver efficiencies which translate to significant cost savings without compromising on quality. Where there might be challenges in recruiting for a study, a Full-Service provider with an established strong site network can work to reduce the risk of missing a deadline. And it is perhaps the complexities of clinical studies that have led to some Full-Service providers offering a hybrid approach - sponsors ultimately want to have access to both options.
Any outsourcing strategy must be workable for both sponsor and service provider. Where outsourcing involves Full-Service or FSP services, it’s normal for the sponsor to work through a procurement group. Before any outsourcing decision, it is essential that the study team correctly inform the procurement group as to their needs. The first key consideration is the nature of the package to be outsourced and how much of the work will be delivered or overseen by the Sponsor. At the extreme ends of the scale, this might be a virtual company outsourcing a single, but complex, study as opposed to a major biopharma company outsourcing a large volume of programming work. In these situations, it might seem obvious that a Full-Service approach is correct in the former case and FSP the latter. However, if the biopharma budgets on a study or Therapy Area (TA) basis, it can become more challenging to operate a successful FSP model. If the study sponsored by the virtual company has complex needs and involves their only product maybe specialist advice will reduce the risk of failure? The desired operational model, the budgeting structure, and the contractual arrangement must all be aligned. Only then can the other elements come into play.
The first consideration calls for an introspective review and in the real world the package or packages of work will not always be as clear cut as those examples above. It may difficult to model how the budgets may breakdown, it may not be obvious what impact shifting timelines will have on resource availability, and the question as to the level of expertise required may be open. At this stage, there may be several outsourcing strategies that appear feasible. Where the sponsor is seeking to outsource a program of studies, it may not be evident as to which methodology is the better fit.
At this stage, the buyer’s operational team must give input and advice as to the nuances of the work and how these will influence the choice of service. The buying team needs to understand how the program may develop based on the success or failure of component trials. If a submission is involved the benefits of one integrated team working to the deadline versus functional teams with the flexibility to grow at busy times can be debated. Is global reach more important than therapeutic expertise, is therapeutic expertise more important than domain knowledge? For smaller companies, the decision might be based more on how much oversight they can provide or how much vendor management they can cope with. It is only after considering the work in detail that the buying team can make an informed decision.
The Changing Climate
In recent years, there has been a shift away from FSP as a cost-saving device. There have been new entrants into the market and the emphasis has been on staff augmentation. The mood is changing somewhat: Sponsors are expecting domain expertise from their FSP providers and quality and innovation feature as much as cost in Requests for Information. The trends toward patient-centricity and data-driven portfolios have focused minds on quality and more in-depth understanding of study design and analytics. The introduction of Machine Learning (ML) and Artificial Intelligence (AI) into study conduct has changed the game again. Domain expertise is becoming more and more critical.
The requirement for highly specialist domain knowledge would suggest the expertise providing under the FSP model is now more important. Sponsors still require the flexibility that FSP brings and will continue to need access to a high number of resources but that will not be enough in the longer term. They will require access to the expertise that comes with specialist providers.
This interesting shift leads to the final consideration. Sponsors need to be building relationships with those companies that can help them deal with new techniques and new technologies. They need to assess where the very best domain knowledge resides and build links with those providers. The Full-Service approach will still provide a large proportion of services for some sponsors, but the complexity of the drug development environment has driven up the demand for specialist providers. Such companies have turned to FSP to scale operations and retained groups dedicated to project-based deliverables to retain the credibility needed to win business.
Sponsors can derive value from both the Full-Service and FSP models. Some Full-Service providers have recognized this and offer a hybrid approach—deploying FSP for components of the drug development process. However, FSP as part of a hybrid model does not deliver the benefits outlined above. Where FSP sits in the Full-Service environment, management, recruitment, and investment are not targeted solely towards the area of specialism. An FSP business unit might have a director, but they will sit on a board bringing together the various players involved in Full-Service delivery. The Full-Service company will attract a different group of candidates. Where Full-Service companies are attempting to establish specialist units, they must consider these factors. Sponsors, in turn, must account for them when selecting a hybrid model.
There are a great many studies that utilise FSP in part and then use one CRO for the remainder of the work. Companies have grown used to this way of working. As study design has evolved and the amount and types of data have increased, the demand for specialist FSP has increased. While a drive for cost savings drove the growth of early FSP arrangements, now a desire for access to specialist expertise plays a significant part too.
Considerations for All Models of Clinical Trials Management
These are some of the areas a sponsor must consider when deciding between a Full-Service approach or bringing in FSP for some services. There will be others especially when the sponsor examines the detail of any package of work. A sponsor can establish key considerations from the project risk assessment.
The market shares of Full-Service and FSP tells us there is a place for both methodologies. We may not have seen the end of the current cycle, which is seeing a trend back towards the FSP approach. It will be interesting to see if the introduction of new techniques coupled with the increasing complexity of drug development will help to power the FSP market to new heights. FSP itself must evolve if that is to happen. If access to expertise is the driving force, then it seems likely specialist companies will underpin such growth. Full-Service companies may respond; we have already seen specialist divisions established within the larger CROs. It is likely we will see further acquisitions of specialist firms as the mid-size and mega CROs seek to meet the demand for expertise.
While these changes occur, it will be more difficult for those charged with procuring services to have a clear view of the best option. Certainly, sponsors will need to look past the marketing of these products and gain a real understanding of the expertise on offer. The implication of this is that smaller companies will need to have access to independent expertise to guide the procurement process and preferably oversight during the study conduct. We have seen the introduction of regulations emphasizing the importance of vendor oversight. As in-study tasks become more technical (think Artificial Intelligence, Machine Learning, new statistical techniques), such monitoring becomes more challenging but also more critical.
For the sponsor the volume of work might be the most important consideration when weighing Full-Service against FSP. Where FSP is procured to deal with a large quantity of work, the risk assessment is different versus the case where FSP is procured for access to expertise. It is this area where we will see companies seeking to differentiate and specialist providers grow to meet the demand.
FSP and Full-Service both have roles to play in outsourced drug development and neither appears to be under threat in the medium term. The nature of clinical trials is evolving, and as regulatory and perhaps political factors shape drug development there may be a swing towards one or the other. Procurement groups will typically work over three-year cycles, occasionally five. These run times will protect them against shifting models which, unless there is a profound change in approach, would take several years to play out.