Introduction
The rise of Functional Service Providers (FSPs) in the field of clinical research implies that biopharmaceutical companies embrace and adapt to change and innovations. Over the years, it is undeniable that conducting a clinical trial has become more challenging, costly, and complex. For companies and organizations that have their in-house clinical research operations department, the common causes of delays and difficulties are expenses, expertise, and schedule adherence. Because of these frontiers, the need for FSPs in the clinical research industry arises to cut excessive amounts of resources without sacrificing the quality and value of the study at hand.
Alongside the advancements in technology and methodologies, the sophistication of protocols and study design also occur while running clinical trials in today’s society. An article published on Applied Clinical Trial’s website entitled “The Rise of FSP Outsourcing in Drug Development” (2020) [1] mentioned that the progressive movement of today’s clinical research influences how biopharma companies outsource important clinical research tasks. The collaborative efforts of clinical research organizations (CROs) and FSPs in the clinical research industry bring forth effective solutions to the ever-changing landscape and ever-increasing demands of performing a clinical study.
What is a Functional Service Provider?
In a simple explanation, Functional Service Providers are contract-bounded companies that carry out a certain job for a client company. FSPs allow outsourcing other aspects of the operations while still having control of the processes and data.
As noted in a published article on Criterium’s website entitled “The FSP: Functional Service Provider in Pharmaceutical Research” (2013) [2], Functional Service Providers offer different kinds of services that a clinical operations department might need help in. The article described the services of FSPs as an “a-la-carte” type basis as pharmaceutical companies can outsource specific tasks in accordance with their budget, schedule, expertise, or other factors.
FSPs are completely different from full outsourcing. In FSPs, biopharma companies will only give certain operational tasks to a Functional Service Provider. This means that the biopharma companies that will avail FSPs services will still have control over the other parts of the clinical operations. In full outsourcing, biopharma companies will completely hand over the operations and all of its necessary processes to an outsourcing company. They will just merely receive the results once the trial is complete.
What is the Importance of FSPs?
According to the published statement of KPS Life’s CCO, Kevin Duffy, on their website entitled “How a Flexible FSP Model Fills the Talent Gap” (2021) [3], the most attainable strategy in achieving standard operational efficiency while cutting the budget dramatically is through FSPs. Furthermore, he stated that FSPs can provide flexibility, adaptability, and speed to biopharma companies.
He also noted in his statement that some pharmaceutical and biotechnology businesses missed the opportunity to sponsor in-house teams to do ClinOps-related tasks locally. Instead, they seek collaborations with independent & specialized service providers to fill in the gaps in their workforce. This provides a quick and cost-efficient opportunity to take over critical positions immediately and provides niche talent pools for the varying needs of the clinical trial.
As mentioned in the article written by Gary Barker, “CRO’s FSP Proves to be the Right Choice” (2018) [4], noted that FSP model delivers on-point scientific results through the ups and downs of the clinical trial lifecycle. FSPs can provide experience and expertise to reduce time and cost while maintaining consistency, integrity, and quality of the processes and procedures of clinical operations.
Top 3 Reasons to Consider FSPs in Conducting a Clinical Trial
According to Freddy Byrth in his published article, “Is a Functional Service Provider Model The Right Fit for Your Clinical Study?” (2018) [5], when there is a need to boost the headcount in an organization, whether it is a need for increased personnel or talent, an HR generalist might become overwhelmed in keeping up with the demand. In this case, FSP is a viable option.
In addition, Bryth (2018), further emphasized that FSPs can supplement and compensate for the changes in work volume or location of clinical operations. Utilizing FSP services to take over some contracts, existing or new, can provide critical stretching of internal resources.
Cost Savings
In a study conducted by Sertkaya, Wong, Jessup, & Beleche (2016) [6], the average expected expense for Phase 1 of clinical trials is around $1.4 million to $6.6 million. In Phase 3, it can even go up to $52.9 million. A whopping 74% of these costs are from human capital namely, procedure, administrative, and site monitoring costs.
According to ProPharma Group in their published article in 2019[7], the cost of onboarding and maintaining employees is eliminated including the scheduling, payroll, and benefits. Furthermore, they emphasized that it is financially beneficial to get an FSP because employees will be working remotely. So, there is no need to rent equipment and office space.
Expertise in Different Aspects
FSPs are made up of experienced experts in their own respective fields of specialization. It is a large team of professionals that comprises exceptional talents ranging from clinical monitoring, data management, medical writing, & biostatistics. FSPs will provide what the clinical operations department is lacking. This can also provide increased productivity, flexibility & risk mitigation.
Control of Data
In comparison with full-scale outsourcing of clinical operations, FSPs allow the original clinical operations department to retain the authority over data. According to an article published on the Turesol Staffing Solution’s website (no date) [8], the biopharmaceutical or biotechnology company retains supervision over data. That means that they are still involved and have authority over the execution of clinical operations.
Conclusion
FSPs are one of the many possible options for clinical operations to minimize risk, cost, and mismanagement while still retaining authority, control, and quality. In the modern era where protocols and technologies are quickly updating, FSPs are the answer to keep up with the increasing demand and challenges that modern medicine is facing.
References
- https://www.appliedclinicaltrialsonline.com/view/the-rise-of-fsp-outsourcing-in-drug-development
- https://www.criteriuminc.com/news-blog/the-fsp-functional-service-provider-in-pharmaceutical-research
- https://kpslife.com/2021/11/how-a-flexible-fsp-model-fills-the-talent-gap/
- https://www.pharmoutsourcing.com/Featured-Articles/350082-CRO-s-FSP-Model-Proves-to-be-the-Right-Choice/
- https://www.clinicalleader.com/doc/is-a-functional-service-provider-fsp-model-the-right-fit-for-your-clinical-study-0001
- https://pubmed.ncbi.nlm.nih.gov/26908540/
- https://www.propharmagroup.com/blog/fsp-for-clinical-development-projects/
- https://turesol.com/10-reasons-functional-service-provider/
