The Functional Service Provider (FSP) models in clinical research are becoming increasingly appealing to the pharmaceutical and biotechnology sectors, offering flexible and scalable solutions to outsource specific functions .
Currently pharmaceutical and biotech companies are facing increased competition and pressure to bring innovative therapies to the market faster, while maintaining high quality and compliance standards.
As this industry landscape evolves rapidly, Functional Service Provider (FSP) models play a significant role in helping organisations to navigate complex challenges and achieve their strategic objectives more efficiently.
Advantages of FSP Models
FSP models serve as a cornerstone in clinical research, offering a variety of advantages, ranging from adaptability and efficiency to reliability and continuity. By leveraging external resources, organisations can navigate the dynamic landscape of research with agility and confidence, in turn optimising performance, and mitigating risks.
Flexibility and Scalability: FSP models empower organisations to dynamically scale resources in response to project demands. This agility enables swift adaptation to evolving priorities, workload fluctuations, and shifting business requirements, ensuring optimal resource allocation.
Cost Efficiency: Outsourcing functions to FSP providers enables cost saving by leveraging their expertise, infrastructure, and economies of scale. This profitable approach minimises overhead costs associated with maintaining in-house capabilities.
Access to Specialised Expertise: Leveraging FSP providers grants access to niche domain expertise across various functional areas such as clinical operations, data management, and regulatory affairs. This specialised knowledge that companies often lack in-house, enhances project capabilities, and fosters innovation.
Focus on Core Competencies: By outsourcing specific functions to FSP providers, companies can redirect internal resources towards core strategic activities like drug discovery and research. This focus enhances efficiency, innovation, and overall organisational effectiveness.
Reliability and Continuity: FSP models prioritise reliability and continuity, laying the foundation for sustained project success and long-term partnerships. Through tailored support and services, FSP providers ensure seamless operations, fostering trust and collaboration.
Risk Mitigation: FSP models play a crucial role in mitigating risks associated with resource constraints, talent shortages, and regulatory compliance. By shouldering responsibility for delivering defined outcomes and meeting performance metrics, FSP providers offer a buffer against project delays and uncertainties.
FSP Models & Solutions
Four FSP models have been dominating the global market, offering the most innovative and flexible solutions. These models cater to different clinical trial set-ups and can be adjusted according to each stage of development.
1. Full Integration into Client’s Team with Functional Roles Solution: This FSP model seamlessly integrates Biomapas staff into the client’s team, operating under their management and adhering to their Standard Operating Procedures (SOPs) and Working Instructions (WIs). By offering functional role solutions, including Line Manager, Quality and HR support staff, we ensure first-rate deliverables while maintaining a collaborative environment.
2. Mixed Model Approach with Functional Roles Solution: In this collaborative approach, both the client and Biomapas contribute their expertise, fostering synergy and optimisation of resources. By blending SOPs and WIs from both parties, we tailor procedures to suit project requirements, promoting flexibility and efficiency.
3. Site Level Solutions: Tailored specifically to site management, monitoring, and Start Up/Regulatory services, this FSP model offers direct contracting between Biomapas and Site Management Organisations (SMOs) or Sites. By providing monitoring services, we enhance study management efficiency while maintaining clear communication and collaboration with all stakeholders.
4. Simple Full-Time Equivalent (FTE) Outsourcing Service: Our comprehensive outsourcing services optimise operational efficiency and resource allocation by offering flexibility, expertise, and scalability. By outsourcing non-core functions, clients can focus on strategic initiatives while benefiting from specialised talent and cost savings.
Among several adaptable FSP solutions, we provide these four most appealing and valued models, tailored to varied client needs, ensuring operational excellence, and driving project success. At Biomapas, we continuously innovate to tailor our FSP solutions to meet evolving industry requirements.
FSP Project Environment at Biomapas: How We Support FSP
Recognising the competitive landscape of FSP clinical research services, Biomapas stands out with its geographical coverage, operational excellence, and unique experience. Our flexible operational model, categorised into Resource Management, Operational Support, and Service Quality, ensures tailored support for each client, fostering collaboration and success.
Geographical Coverage
Geographical representation is a pivotal aspect of FSP model success. With coverage spanning over 30 countries through European Union (EU), non-EU, Commonwealth of Independent States (CIS), and the Eurasian Economic Union (EAEU), Biomapas guarantees extensive reach across diverse regions, enabling swift response times and seamless resource allocation tailored to meet client demands.
Resource Management in FSP Model Implementation
Effective resource management is essential for the successful development of FSP models, which demand high qualifications, experience, and productivity from resources. The process encompasses four key components:
1. Search, Assignment & Onboarding: Our recruitment department collaborates closely with the Clinical Operations (CO) management team to identify and onboard the most suitable resources. Utilising referrals, recommendations, and mutual interviews, we establish a robust resource network spanning EU and non-EU countries.
2. Workload Management: Resources are assigned to projects by dedicating resources to one major FSP client or a maximum of two smaller clients. Regular reviews and revisions of resource allocation ensure optimal workload distribution.
3. Performance Management: Biomapas staff working under the FSP model align with client values, KPIs, and managerial styles. Regular calls between Line Managers (LMs) and employees, as well as Single Point of Contact (SPoC) and clients, monitor performance and facilitate feedback collection to maintain alignment and ensure continuous improvement are set up for every FSP client.
4. Recognition Management: Our ongoing achievement recognition and annual performance evaluation programmes motivate employees and support their development within the FSP framework.
What kind of Operation Support can clients expect?
Single Point of Contact (SPoC): An experienced managerial-level employee serves as the main contact for regional study strategy, resource allocation, and project oversight. SPoC facilitates efficient communication, enhances relationship building, and promotes synergy between Biomapas and clients.
Country Expertise: Biomapas provides comprehensive support in country-level study activities, including capability assessment, feasibility analysis, and regulatory compliance. Drawing on our extensive experience, we offer tailored solutions to overcome challenges and optimise study setup.
Management of Challenges: In the face of obstacles such as recruitment delays or customs clearance issues, Biomapas mobilises a multidisciplinary team comprising SPoC, Country Heads, CRAs, and Quality Assurance (QA) experts to provide timely support and resolution.
KPI Oversight and Management: We align with client KPIs, regularly sharing reports with SPoC, and taking necessary actions to ensure compliance and service quality.
How does Biomapas ensures Service Quality?
Internal Quality Control (QC) Process: Biomapas maintains rigorous internal QC processes to uphold service quality, including submission package review, legislative compliance monitoring, and IP release validation.
CRA Accompanied Visit: LMs or designated personnel conduct regular CRA accompanied visits to reaffirm CRAs’ qualifications and ensure adherence to SOPs, with visit report quality reviewed and discussed afterward.
Site Risk Assessment and Compliance Visits: Biomapas conducts site risk assessments twice a year to evaluate CRA experience, protocol risks, and recruitment trends, with additional compliance oversight visits conducted by the QA team as needed.
HR Support: Our HR department drives staff education and qualification through comprehensive training programmes, including therapeutic area training, and soft skills development.
The Bottomline
In the dynamic realm of clinical research, Functional Service Provider (FSP) models are indispensable for the pharmaceutical and biotechnology sectors. With over a decade of expertise, Biomapas tailors FSP solutions to diverse client needs, driving operational excellence and project success.
Our comprehensive services span resource management, operational support, and service quality, ensuring seamless collaboration and success. With geographical coverage across 30+ countries in the European Union (EU), non-EU, Commonwealth of Independent States (CIS), and the Eurasian Economic Union (EAEU), Biomapas ensures extensive reach and swift response times, facilitating efficient resource allocation. As the industry evolves, FSP models remain crucial for navigating challenges and achieving strategic objectives effectively.
