The strategic selection of an appropriate functional service provision (FSP) partner is crucial for biotech and biopharma organizations if they want to maximize quality, financial efficiency, and operational effectiveness. However, achieving a gold-standard partnership is an ongoing journey, and the selection of an appropriate partner is the beginning and not the end of that journey.
To achieve gold-standard partnerships, organizations need to understand the role of FSPs, optimize partner selection, consider how their needs might evolve, and put in place frameworks to navigate and overcome challenges.
The Role of FSP Strategic Partnerships
FSP partnerships differ from a full-service model because vendor staff use sponsor systems and processes. They are also invoiced on a full-time equivalent (FTE), rather than a unit or deliverable basis. FSP types range from staff augmentation to autonomous teams, usually driven by the organization's size and maturity.
In a large pharma company, there might be an FSP team of 100 FTEs supporting project delivery with a project lead part of the sponsor’s operational management team. This kind of partnership can be co-developed based on KPIs and process improvements and a flexible model can ensure resources can be repurposed easily across projects.
In growing biotechs, we are seeing companies move away from a ring-fenced full-service model and converting ring-fenced FTEs from unit-based delivery to FSP FTEs to enable easy movement of resources. This allows FSP FTEs to move from, for example, vendor systems/processes to biotech systems/processes, as the sponsor’s biometrics teams grow.
When thinking about the type of FSP model that is right for your organization it is important to consider the evolution of artificial intelligence (AI) and automation and what skill this requires, how the FSP model might evolve, and issues like preference on staff location and hiring requirements.
Selecting the Right FSP Partner
Selecting the right FSP partner is a journey. The first step is to consider your business requirements. What capabilities do you need? For example, clinical operations, quality, data management, or pre-clinical? How big is your program going to be and what are the short, medium, and long-term objectives?
What type of service provider do you need? Is a CRO, function-specific provider, or niche provider going to be most appropriate? This is likely to become an ever-more important consideration as specific expertise is needed to seize the opportunities offered by new technologies and advancements in artificial intelligence (AI).
What is your budget? What is your governance model? Who will manage the relationship and what escalation pathways will be in place
Finally, how will you operationalize your program? What systems will you use? Will you be operating on a global or regional scale? What key performance indicators (KPIs) will you have in place?
Once you have answered these questions, you can move on to the next step in your journey – starting to think about how you want your program to evolve over time. How will you leverage your partner’s experience? How will governance, operations, and technology evolve? Is there scope for continuous reevaluation and improvement?
Each partnership has very different needs. It will depend on the type of engagement, the global reach, sourcing capacity, ty and staff skillsets required. However, there are some overarching qualities of a potential gold standard partner.
Look for an outsourcing provider with a customer-focused approach to clinical development and the ability to deliver customized solutions tailored to your specific requirements. They should have the logistical infrastructure for timely project launches, be able to adhere to any budget constraints, and offer continuous provision of essential staff and services to adapt to changing needs.
Global FSP Partnership Considerations
There are five core areas of consideration for global FSPs – expertise, resource capacity, cost efficiencies, consolidated governance, and whether a global or regional approach is most appropriate.
It is crucial to work with a partner who can offer local regulatory expertise even if they operate on a global scale. You should also consider the partner’s ability to ramp up capacity, their stability, and whether there are any mutual-complimentary footprints. Taking advantage of global options can deliver cost efficiencies by allowing you to find a model that delivers cost, quality, and speed. Consolidated governance can also reduce the burden on performance management, resource management, value-adding, and value creation.
When deciding between global versus regional, consider whether one solution is required to support all activity or whether region-specific solutions are more appropriate. You can also utilize time zone advantages. Cultural fits can be very important, such as both parties understanding how the global organization functions.
Building Communication Channels
Once you have selected your strategic FSP partner it is crucial to build effective communication pathways. While one size does not fit all, establishing a partnership framework based on clear communication from the start can help avoid future problems.
A written FSP partnership manual should set out clear goals and desired outcomes, along with key roles and responsibilities. This should align with FSP roles and responsibilities and set out where the point of contact sits in the partnership.
Decide what platforms and systems will be used to manage the relationship and how they will be managed. For example, shared platforms, meeting forums, and locations.
Establish guidelines and templates for communication, this should include a clear communication plan, reporting mechanisms and dashboards, guidance, and key contacts.
Importantly, ensure lines of communication always remain open and there are clear escalation pathways for any issues which arise.
Partnership Development
As your partnership develops, you may encounter challenges. However, these can be overcome with a well-defined contract and framework, a flexible partnership model, innovative solutions, and a cycle of continuous improvement.
At an executive level, a holistic review of the engagement should include the application of continuous improvement initiatives and the identification of partnership development measures. At a functional level, broader needs of the engagement should be identified through KPI review, implemented initiatives, and constructive feedback. At an operational level, both partners should be made aware of the current requirements of engagement via status updates.
Key Learnings for a Gold Standard FSP Partnership
When it comes to implementing a global-standard FSP partnership, both sponsors and partners have a role to play. Sponsors must provide clarity on roles and responsibilities, particularly the management of FSP staff, and comprehensive training on their systems. It can help to start small and work with the vendor to set and check expectations.
Partners must understand the sponsor’s key requirements, especially the skillsets required. They should proactively manage staff and projects rather than assuming the sponsor has oversight and understands staff development possibilities and constraints. Most importantly, they should be flexible to ensure they can meet the sponsor’s needs.
By building good-standard partnerships, biotech, and biopharma companies can ensure they maximize quality, efficiency, and operational effectiveness. The importance of these strategic partnerships is only set to increase as new technologies require new levels of expertise and the clinical trials industry evolves to meet the challenges of digital health and increasing data sources.
Author Details
Elisa Mansfield- Vice President, FSP, Phastar
Having started in the pharmaceutical clinical trial sector over 30 years ago in Statistics, Elisa Mansfield has worked within pharmaceutical and CRO arenas providing multinational leadership for Data Management, Programming, and Statistics. Elisa’s passion is “all about the data” and its contribution to scientific advancement. She fully advocatesBiometrics'ss fundamental role in the collection and reporting of data, bringing technological advances and analytical techniques to the fore. She is responsible for directing the Biometrics FSP Operations at Phastar and, as part of the Senior Management team, providing business insights to drive forward the Company’s key principles. Elisa is a Chartered Statistician and remains an active member of the industry.
Publication Details
This article appeared in Pharmaceutical Outsourcing:Vol. 25, No.4 Oct/Nov/Dec 2024Pages: 14-15