The Functional Service Provision model has existed in the pharmaceutical industry for almost two decades, originally designed by large pharmaceutical companies to deal with short-term resourcing needs. This model has changed over the years to meet the needs of a wider variety of pharmaceutical companies and the growing demand for resources as well as to combat significant increases in drug development costs.
While traditional FSP relies on a team of resources in a specific area in order to provide Sponsors with scalability and flexibility, companies are also looking at a FSP/Full Outsourcing hybrid model in order to meet the demands of rising costs while maintaining quality clinical data.
How can Small & Medium Enterprises incorporate this outsourcing model into their strategy?
Do you have an internal biometrics team?
Do you have a need for additional resources?
Do you have unique trial needs?
Is price your primary concern?
SMEs most likely will not need large teams of programmers or data managers, nor will they necessarily have the resources to set up internal biometrics departments.
One of the biggest challenges of SMEs is that they usually find themselves in unpredictable situations with varying workloads and pipelines, and it is often more difficult for SMEs to adapt to these fluctuations especially in the short to medium-term.
SMEs are logically concerned about pricing structures and quality services. They are also looking for the attention normally reserved for large pharma when it comes to supplying quality data services and demonstrated experience and expertise.
These requirements do not impede an SME from benefiting from the FSP model, and CROS NT proposes a 5-point FSP model driven by the concept of “Sustainable Quality” scalable to meet the needs of SMEs.
1. Strategic Pricing Structure: SMEs need pricing models that are flexible to company needs but do not fluctuate unexpectedly. The FSP model aims to lower customer overheads including administrative costs of employee personnel, recruitment fees and management of administration and human resources tasks. This meets the particular needs of SMEs who are not looking to set up internal biometrics departments and reduce company overhead costs through outsourcing.
2. Sustainable Quality Deliverables: Flexible pricing structures and careful planning of team growth, supported by KPIs developed to generate visibility and support efficient oversight, allow CROS NT to maintain a sustainable level of quality throughout the contract, ensuring the SME is fully supported by the FSP team delivering at the agreed quality levels.
3. Demonstrated Expertise: SMEs pursuing the FSP model are looking for the same expertise and deliverables as large pharma companies. This model guarantees the right biometrics expertise match based on study and therapeutic area needs. SMEs can work with their CRO to recruit necessary resources by geographic area, therapeutic area and subject matter (for example, expertise in CDISC mapping). The CRO works with the resource to build their training, learning and progression.
4. Human Resources & Cultural Element: Working in an SME environment can be challenging for new resources, and many SMEs don’t have the capacity of large pharma companies to implement extensive HR functions. The FSP model for SMEs puts these responsibilities in the hands of the CRO to guarantee coverage of sick leave, holidays and absences as well as progession and succcession planning. In the CROS NT model, we include HR considerations in order to evaluate cultural fit and and skills requirements and a plan to scale up quickly in necessary.
5. Communications & Integration Management: CROS NT’s FSP model guarantees a dedicated FSP Manager leading the integration of the team, managing the initial training, technology and SOPs and processes. Throughout the relationship, the FSP Manager supervises workload, priorities and deliverables, reducing the burden on the SME personnel. A collaborative communication strategy is developed to ensure multi-level and seamless communication and to build an effective governance structure.
SME Special Considerations in Clinical Trials
Are you an SME conducting trials or other regulated data activities? Do you need additional resource, but are not sure what expertise to recruit? Contact CROS NT about our niche FSP solutions for SMEs. We can support with a variety of resources, and bring them together to supplement the needs of your organization. CROS NT can be of particular support to SMEs conducting trials in both the United States and the European Union with regulatory support specific to SMEs.