Background
In the fiercely competitive pharmaceutical industry, efficient and effective clinical development processes are
imperative for success. Large global pharma companies face the challenge of managing numerous aspects of
clinical trials, including scientific research, data management, regulatory compliance, and communication
strategies. To streamline these operations and optimize resource allocation, many companies turn to Functional
Service Provider (FSP) models. Our client, a leading global pharmaceutical company, embarked on a journey to
develop a groundbreaking therapeutic product targeting a prevalent medical condition. Given the complexity and
global scale of the clinical development program, they sought a strategic partner to support their clinical operations.
Challenge
The client faced several challenges in executing their clinical development program:
– Resource Allocation: Managing a diverse team of professionals with specialized skills across various functional areas.
– Efficiency: Ensuring seamless coordination and communication among different stakeholders to maintain project timelines and budgets.
– Regulatory Compliance: Adhering to strict regulatory guidelines and standards throughout the development process.
– Data Management: Handling vast amounts of clinical data while maintaining accuracy, integrity, and confidentiality.
– Scientific Innovation: Incorporating the latest scientific advancements and methodologies into the clinical research process.
Solution
To address these challenges, the client opted for a Functional Service Provider (FSP) model, partnering with a specialized organization that could deliver tailored solutions across multiple functional areas. The FSP provider collaborated closely with the client’s internal teams to support various aspects of clinical development. Below are some key roles and responsibilities within the FSP model:
– Associate Scientist: Conducted laboratory experiments and data analysis to support preclinical research activities.
– Clinical Project Scientist: Provided scientific expertise and strategic guidance throughout the clinical trial phases.
– Epidemiologists: Conducted epidemiological studies and analyzed population-level data to assess safety and efficacy profiles.
– Real World Evidence Strategic Leader: Designed and implemented real-world evidence strategies to complement traditional clinical trial data.
– Drug Safety Associates: Monitored adverse events and ensured compliance with pharmacovigilance regulations.
– Medical Communications Specialists: Developed communication strategies and materials for both internal and external stakeholders.
– Project Specialists (Temperature Management & Control): Oversaw logistics and quality control measures for temperature-sensitive products during clinical trials.
– Clinical Trial Assistants: Provided administrative support and maintained trial documentation.
– Compliance Specialists: Ensured adherence to regulatory requirements and internal policies.
– Technical Writers: Prepared documentation, including study protocols, clinical reports, and regulatory submissions.
Results
The implementation of the FSP model yielded significant benefits for the client:
– Cost Efficiency: By insourcing specific functions to specialized providers, the client optimized resource allocation and reduced operational costs.
– Streamlined Operations: The FSP model facilitated seamless coordination among various functional teams, resulting in improved project timelines and efficiencies in finding the right talent globally.
– Regulatory Compliance: With the expertise of regulatory specialists embedded within the FSP team, the client achieved compliance with relevant regulations and standards.
– Data Integrity: Robust data management practices fueled by the niche workforce ensured the accuracy, integrity, and confidentiality of clinical trial data.
– Scientific Innovation: Leveraging the expertise of diverse professionals within the FSP model enabled the client to incorporate cutting-edge scientific methodologies into their clinical research.
