Pharma and biotech companies often face the challenge of needing additional biometrics support, whether due to a full outsourcing strategy, slow hiring processes, or busy periods with conflicting priorities. When addressing this gap, two common approaches are project-based outsourcing (PBS) and Functional Service Provision (FSP).
PBS involves outsourcing some or all biometrics components bundled with or separately from clinical operations. On the other hand, FSP can be thought of as “insourcing” additional resources, where the provider works closely with the sponsor to integrate team members into the internal structure. FSP teams operate under the sponsor’s systems, SOPs, and use sponsor-based email addresses, ensuring seamless integration and coordination.
One key advantage of FSP over direct hiring is that team members remain employees of the provider organization, alleviating administrative costs and employment risks for the sponsor. This approach can be more cost-effective and less risky, especially for scaling internal teams.
Although FSP agreements are often associated with large-scale placements, it’s worth highlighting that FSP doesn’t have to involve large numbers. Any company can benefit from an FSP, even if they only need a few additional team members or a partial/part-time placement. In these cases, partnering with small-to-mid-size providers can lead to the most success, as they can offer customized solutions tailored to specific needs.
When considering an FSP arrangement, several key criteria contribute to successful implementation:
- Internal Structure: Having functional knowledge in-house is crucial as internal subject matter experts (SMEs) will manage and guide FSP team members, serving as technical line managers.
- Specific Project Needs: Clarify whether the FSP team will perform project work or provide oversight to CROs. Aligning expectations leads to greater satisfaction.
- Current Resource Needs: Determine if you require full or fractional roles and how many FTEs are needed. Choose an FSP provider based on your specific resource requirements.
- Resource Needs for the Future: Consider your resource needs for the next 1-3 years. Collaborate with the FSP partner to plan for growth and ensure a cultural fit between both organizations.
In summary, leveraging an FSP approach can offer tailored biometrics support, cost-efficiency, and flexibility for pharma and biotech companies looking to expand their capabilities.
Understanding Biometrics Functional Service Provision (FSP)
Interested in learning more about Biometrics FSP approaches? We’ve compiled a FAQ to help you choose your best approach.
What is Biometrics Functional Service Provision (FSP)?
Functional Service Provision (FSP) is a model where an external provider collaborates closely with a sponsor organization to integrate additional resources into their internal structure. FSP teams operate under the sponsor’s systems, SOPs, and use sponsor-based email addresses, ensuring seamless integration and coordination. Essentially, it’s like “insourcing” extra support to augment the sponsor’s existing team. For Biometrics groups, this means adding team members in Data Management, Statistics, Statistical Programming or Medical Writing.
How does FSP differ from project-based outsourcing (PBS)?
While PBS involves outsourcing specific biometrics components, either bundled with or separately from clinical operations, FSP focuses on integrating additional resources directly into the sponsor’s internal structure. FSP offers a more integrated approach, where team members work closely with the sponsor’s team, following their processes and working practices.
What are the advantages of choosing FSP over direct hiring?
One key advantage of FSP is that team members remain employees of the provider organization, alleviating administrative costs and employment risks for the sponsor. This approach can be more cost-effective and less risky, especially for scaling internal teams. Additionally, FSP offers flexibility in resource allocation, allowing sponsors to adjust team sizes based on project needs.
Does FSP always involve large-scale placements?
No, FSP doesn’t have to involve large numbers. Even companies needing only a few additional team members or part-time placements can benefit from FSP. Partnering with small-to-mid-size providers can offer customized solutions tailored to specific needs, ensuring cost-efficiency and flexibility.
What key criteria should be considered when implementing an FSP arrangement?
Several key criteria contribute to successful implementation of an FSP arrangement:
- Internal Structure: Ensure you have functional knowledge in-house to manage and guide FSP team members effectively.
- Specific Project Needs: Clarify whether the FSP team will perform project work or provide oversight to CROs to align expectations.
- Current Resource Needs: Determine if you require full or fractional roles and choose an FSP provider accordingly.
- Resource Needs for the Future: Collaborate with the FSP partner to plan for growth and ensure cultural fit between organizations.
Conclusion:
Understanding Functional Service Provision (FSP) and its benefits can help pharmaceutical and biotech companies optimize their biometrics support. By choosing the right FSP provider and considering key implementation criteria, organizations can leverage tailored support, cost-efficiency, and flexibility to expand their capabilities effectively.