Implementing a Gold Standard FSP Strategic Partnership

Elisa Mansfield, Vice President, FSP, Phastar

The drug development landscape is continuously evolving. This evolution is ushering in a new age of outsourcing as traditional models adapt to meet new demands, priorities, and challenges. The strategic selection of an appropriate functional service provider (FSP) partner is vital for maximizing quality, financial efficiency, operational effectiveness, and overall success. But how can biotech and biopharma organizations ensure they choose the right partner for their clinical development program?

Fundamentals and evolution of FSP strategic partnerships

The FSP model allows sponsors to tap into in-depth domain knowledge and cutting-edge expertise in new techniques and technologies. In a new era of outsourcing, working with an FSP is no longer just about contributing to technical projects as a team or individual. Instead, FSPs are supporting sponsors through strategic oversight and by leveraging business operations data to sustain clinical development and reporting.

The specific type of FSP chosen is usually driven by the size and maturity of the sponsor organization. For example, a large pharma company was provided with more than 100 full-time equivalents (FTEs) to support project delivery. These FTEs were split into different teams, each with its own project lead who was part of the sponsor’s operational management team. This allowed project leads to understand the sponsor’s systems and processes and keep up with any new developments in the company. They could also give feedback on the stage of the project in real time to management. Because of this close partnership, the sponsor and FSP could develop joint key performance indicators (KPIs) and help with process improvement. This approach also provided a flexible model where resources could be repurposed easily across projects.

In a growing biotech, moving from a ring-fenced full-service model to FSP FTEs allowed easy movement of resources. As the organization continued to grow, the FTEs moved from the vendor’s systems and processes to the biotech’s systems and processes, helping the biometrics team to grow.

These are just two examples which demonstrate the flexibility of the FSP model and how it can be adapted to meet the needs of different organizations, regardless of size.

Choosing the right FSP partner

When choosing an FSP partner, it is important to be clear about what you are trying to achieve and the specific expertise that is going to add value to your organization, ultimately saving you time and money.

Start by thinking about your business requirements and what capabilities your company needs. Consider how big your program is going to be and what your short-, medium-, and long-term objectives are. You may also need to consider the growth of your own organization; will you require a partner with the ability to scale?

There are also practical considerations. Decide on your budget and governance model and how you will operationalize your program, including the systems you will use and any KPIs. It is also important to consider your hiring requirements. Do you want your FSP vendor to do all the hiring or do you want to do some of the interviewing or vetting?

Once you have identified your requirements and objectives, look for an FSP partner who will allow you to harness specific domain expertise, while also driving quality and innovation. Think about whether they will be able to adapt and offer flexible support as your business grows or your requirements change.

If you are looking at a global FSP partnership, there are additional considerations to weigh. A global partnership can offer cost efficiencies, diversify risks against market shifts, and offer opportunities to ramp up. It can also consolidate governance, reducing burden on performance and resource management. However, you will need to consider whether you want one global solution or region-specific solutions and how to ensure both parties understand how the global organization functions. You should also ensure your chosen partner can offer local regulatory knowledge as well as global and specialized therapeutic expertise.

When choosing the right FSP partner, it is also vital to consider the people and culture of the partnering organization. Considering a team with high staff retention could provide the continuity and consistency of work needed for an effective partnership. But retention is just part of the equation; you may want to also consider the quality of the people. In order to harness this, you must not only target potential partners that have a strong workplace culture that appeals to talented candidates, but also can retain that talent through a continuous focus on professional development and growth. For example, a strong FSP partner would maintain a best-in-class clinical development team capable of executing your study from beginning to end through implementing a comprehensive strategy. This includes an effective recruitment model, training, and ongoing initiatives to engage, develop, and retain employees.

Successfully evolving your program

Selecting an FSP vendor is just the start of building a gold standard partnership. You also need to consider how your program is going to evolve and how you will leverage your partner’s experience. Consider technology, governance, and operational evolution—and how you will set up a continuous cycle of reevaluation and improvement.

You should define a partnership framework, ideally from the outset of the project. Write your plan down to establish an FSP operating manual that covers key areas, such as documentation storage. Make sure the manual is shared with all relevant stakeholders and revisited frequently to ensure it is still fit for purpose. Your partnership framework will help you determine the types of communication channels that you need, allowing you to build upon the goals and requirements you determined at the outset.

Once a framework is established, there are some key elements to consider when looking at the communication pathway. From the outset, build key points of contact and align them with roles and responsibilities. Consider who the stakeholders are, who needs to get involved in decision-making, who needs to be informed, and who the key operational contacts are. Think about what platforms and systems will be used to manage the relationship, including meeting forums and locations.

Navigating partnership hurdles

In any FSP partnership, there will be the need to address challenges and identify new solutions. A clearly defined partnership framework, as outlined, will help you navigate these challenges more naturally by, for example, implementing communication and escalation pathways.

Transparency is one of the first key steps to ensure open and objective discussions when challenges do emerge. Remember to utilize cross-functional expertise and knowledge and include the right points of contact in discussions. It is also important to recognize that each engagement is very different. You may require tailored and innovative solutions and collaboration and insightfulness across both partner companies. Bear in mind that a solution that works at the beginning of a partnership may need to adapt and change as requirements evolve. Continue to build on your communication framework and refresh as required to meet these evolving needs.

Both sponsors and FSP vendors have a role to play in ensuring a partnership is successful. Sponsors should provide clarity on roles and responsibilities, provide comprehensive training on systems, and work with the vendor to set and check expectations. The FSP vendor must ensure they understand the specific skills required by the sponsor, proactively manage staff, and offer flexibility. Ultimately, the partnership working is key.

The future of FSP

We are already in a new age of outsourcing, but the current technological and research landscape means we can expect to see further changes in vendor models and new opportunities to further enhance the ability for partnerships to work. We need to consider the workforce skillsets that will be required as artificial intelligence and automation continue to evolve and how a changing pharmaceutical landscape, including the rise of digital health and real-world evidence, is shaping needs.

By implementing a gold standard biometrics FSP partnership, sponsors can not only meet the challenges of today’s clinical trial landscape, but also prepare for the changes to come. Ultimately, a successful partnership can increase quality and operational effectiveness, saving time and money and increasing overall success.

Elisa Mansfield is Vice President, FSP, Phastar