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Clinical and regulatory teams face increased pressure to drive uninterrupted progress across the clinical development pathway. These teams routinely benefit from the support of an external partner who can minimize the risks of failure and missed milestones while at the same time offer supplemental expertise to improve the likelihood of commercial success.
Given the number of options, deciding on the right partner to augment your internal resources and advance your clinical trial can be challenging. Trial sponsors may seek out a service provider with the capabilities to handle all aspects of the study from end-to-end, or may decide to look for a specific service capability, or may choose to tap individual experts or a team of experts and bring them in-house. It boils down to defining/refining your needs and finding a proven partner who can adapt and flex to your unique requirements.
This blog highlights key points to consider when deciding if a functional service approach could serve you and your study well.
What is a Functional Service Provider (FSP)?
A Functional Service Provider (FSP) can have different meanings depending on whom you ask. At Veristat, we offer two different solutions under our FSP model, both of which can be further tailored to meet a client’s unique needs:
- The first is an outsourced approach in which Veristat provides targeted service solutions to a sponsor, such as data management or medical writing, using Veristat’s internal systems, processes, and procedures with related infrastructure
- The second model is an in-sourced strategic resourcing approach where Veristat provides individuals or teams to a sponsor on a contracted basis. These resources are then managed by the sponsor using the sponsor’s own systems and procedures. In-sourced strategic resourcing can also be structured as a hybrid model in which a determined level of Veristat’s oversight and processes are integrated into the sponsor’s.
Considerations when evaluating an FSP model
The following are three critical factors to help you decide if an FSP model is right for you.
1 - Your organizational readiness and management expertise
Clinical teams that choose to in-source their study activities by bringing in individual experts or teams in-house want to avoid using an outside resource to manage their key functions. Reasons behind their decision may be that they’ve experienced problematic occurrences with a service provider in the past, or may have limited experience outsourcing any or all aspects of a study. Additionally, management may decide that having one-on-one, hands-on relationships with in-sourced resources could provide underlying benefits such as:
- Improved team morale
- On-the-job learning when working closely with staff
- More flexible functional utilization
- Direct oversight of in-sourced resources
One clinical operations expert recently shared that he considered his in-sourced FSPs to be a true extension of his internal team, encouraging them to share best practices, take ownership of their contributions, raise concerns, and boldly bring potential solutions forward.
When weighing your options, it is important to take an objective point of view regarding your capacity to manage in-sourced resources. Whether you are an emerging, small, or large biopharma, you may not possess the infrastructure needed to succeed, especially when operating under compressed timelines and/or unexpected occurrences. In this instance, it may be a more prudent move to secure a partnership with a service provider who can offer targeted support for the services you need, where you rely on their experts to assume important operational and oversight responsibilities. Outsourcing to a specialized service provider also gives you access to a deep bench of experts who keep pace with the latest in regulatory requirements, offering you an added level of compliance assurance.
2 - The cadence of study demands
The influx of work can vary dramatically daily, weekly, and month to month. Bringing in contracted staff during times of intensity can be a great help in meeting deadlines. The issue is whether it is a smart move to use your internal resources to seek out the necessary staffing as your needs dictate, or rely on an outside partner to take this on. Working to augment critical functions can be time-consuming, and using team time wisely is an important factor in the clinical development process. Tapping the services of a proven FSP provider means you will have the advantage of a large pool of specialized talent to match your study requirements quickly and expertly.
When we asked our clinical operations expert for his perspective on how he addresses fluctuating study demands, he shared that having an FSP provider at his disposal, and one who actually understood his wants and needs, was an incredible help, saving him time and headaches. In a one situation, he had only a few weeks to meet a critical timeline and needed expert help in Statistical Programming within CDSIC standards for an FDA submission. He knew that, as a small biopharma, a larger clinical service provider would not have given him the time or attention to quickly and effectively address his needs. Fortunately, the FSP provider he selected came through with a series of qualified experts who helped accelerate the completion of his deliverables for submission.
A reputable FSP provider will work closely with you to help ensure that, together, using well-vetted contracted experts, you will achieve your goals.
3 - Your desired level of flexibility
Flexing and adapting to your clinical study's changing needs and conditions is paramount in an ever-evolving clinical research operating environment. An FSP model, whether in-sourced or out-sourced, offers added flexibility by integrating on-demand resources where and when needed. You avoid making a long-term outsourced partnership commitment when faced with a host of significant unknowns. It's also much easier to scale up or down with outsourced resources than with employed staff. Additionally, an FSP model allows you to “test the waters” with a service provider if your needs expand to the point where full-service support would be of considerable value.
Staffing solutions to accelerate clinical development milestones and support study success
As a global clinical research organization (CRO) that delivers bold thinking to make the impossible possible, Veristat has aggregated significant and relevant experience collaborating with sponsors and providing the operational, scientific, functional, and/or therapeutic expertise required to conduct their clinical trial from start to finish. Given this, we possess a valuable perspective on the rapidly changing talent sourcing landscape. Certain clients need in-sourced resources to manage a specific challenge. Others require a functional service or full-service solution. No matter the engagement model, there are several considerations that we believe foster quality standards likely to promote increased return on a sponsors’ investment, and include:
Confidence and trust: A willingness to identify complex needs quickly and find solutions; a partnership that anticipates future requirements.
Consistent collaboration: Regular interactions to identify, understand and resolve your project challenges.
Discipline: Rigorous, repeatable processes always directed toward solutions.
Transparency: Every action is clear and visible to stakeholders.
Flexibility: The commitment and work ethic to anticipate and adapt to your evolving needs.
Whether you need a few scientific experts or a fully-staffed function, gain flexibility and results with Veristat and confidently meet your study milestones.
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