Clinical Trial Experts on Demand: How Functional Service Provider Solutions Can Level Up Your Trials
Today’s study demands are complex and ever-changing. Sponsors face challenges such as quickly supporting and expanding their clinical trial teams with additional scientific and technical expertise.
Few central labs provide Functional Service Provider (FSP) Solutions which can help overcome this hurdle by offering access to highly specialized skills and knowledge that sponsors may lack in-house. This expertise is critical for navigating the complexities of modern clinical trials, regulatory compliance, and data management.
Unlike traditional full-service outsourcing, an FSP model focuses on providing specific services or functions like scientific project management, biospecimen management, and lab vendor management. This approach allows sponsors to retain control of their trial and data while enhancing the flexibility and efficiency of their team with specialized skills and expertise on an as-needed basis.
Adoption of Functional Service Provider Solutions Is Increasing
Studies indicate that the adoption of FSPs by major biopharmaceutical corporations is experiencing an annual growth rate exceeding 13%. This growth can be attributed to several key factors, including:
- Increased R&D Investment: The pressure to accelerate drug development timelines and reduce costs, while maintaining high quality and compliance, drives sponsors toward FSP models to stay competitive in a fast-paced global market.
- Cost Efficiency: Partnering with FSPs can be more cost-effective than maintaining a full-time, in-house team for every function. It allows sponsors to convert fixed labor costs into variable costs that can scale up or down based on project needs.
- Technological Advancements: FSPs often invest in cutting-edge technologies and platforms, offering their clients the benefits of these tools without direct investment. This includes data management systems, analytics tools, and patient recruitment technologies.
- Increased Complexity of Clinical Trials: As clinical trials become more complex and specialized, the need for specific expertise and capabilities that FSPs provide has grown. This includes managing multi-regional trials, complex data, and specific therapeutic area knowledge.
The Impact of Understaffing on Clinical Trials
Understaffing in clinical trials can lead to operational challenges, including delayed timelines, compromised data integrity, and inflated costs. When a project is not sufficiently staffed, the remaining team members are often stretched thin, attempting to cover multiple roles. This can result in missed deadlines as tasks take longer to complete, slowing the development process. The pressure and rush can also lead to errors, compromising the integrity of trial data—data that is crucial for regulatory approval and the safety of future patients. This causes the potential need to redo work because of errors which can significantly impact the financial scope of the project.
FSPs possess the network needed to quickly place skilled professionals tailored to the specific needs of a clinical trial. Whether it’s a sudden need for data managers, biostatisticians, clinical monitors, or other technical or scientific experts, FSPs can fill these roles, ensuring that trials continue to run smoothly without disruption. This agility in staffing not only helps maintain timelines but also safeguards data integrity by ensuring that tasks are performed by well-trained professionals.
Enhancing Trial Success with Scientific Laboratory Consulting
Leveraging specialized expertise can make the crucial difference between success and setbacks. When coupled with scientific laboratory consulting services, FSP solutions offer a wealth of know-how and bring an invaluable fresh perspective to clinical trials. Experts armed with extensive experience and up-to-date knowledge of industry trends, serve as an additional set of fresh eyes, complementing internal teams. This fresh perspective injects new insights into the analytical lab strategy in clinical trials from protocol optimization through regulatory submission, including oversight of routine and complex labs, and validation of assays.
At LabConnect, we offer a unique consulting model that provides highly qualified Laboratory Scientific Consultants who seamlessly integrate into study teams. These experts serve as both scientific and technical advisors, conducting thorough operational reviews of protocol analytical plans with a focus on optimizing data endpoints to support safety and efficacy. Throughout this process, we prioritize simplifying biosample requirements to enhance patient participation and alleviate site workload burdens.
Choosing the Right FSP Partner
FSPs are designed to seamlessly integrate with an organization’s internal processes, offering scalable solutions that can be tailored to meet the needs of the clinical study. By leveraging the deep knowledge and operational excellence of FSPs, sponsors can optimize their resource allocation, mitigate risks associated with understaffing, and ensure the successful execution of complex trials.
To learn insider tips on how best to support clinical trials with LabConnect’s FSP model, register for our upcoming webinar today.