5 Proven Strategies for Effective Management of FSP in Clinical Trials

Clinical trials are an integral part of the drug development process, involving careful planning, coordination, and management. The progress of clinical trials hinges on the ability of the sponsors to manage a range of complex and interdependent activities, from study design and protocol development to regulatory compliance, data collection, analysis, and reporting.

Effective management of Functional Service Provider (FSP) is an essential component of clinical trial management, as these specialized service providers bring expertise, experience, and resources to the table. FSP can help sponsors save time, reduce costs, and mitigate risks, but only if managed effectively. As such, FSP management is crucial to ensuring that the clinical trial is conducted ethically, efficiently, and safely, which ultimately benefits patients, healthcare providers, and society as a whole. Using case studies as examples, we can see the significance of FSP management in clinical trials.

Case Study 1: A healthcare conglomerate in Florida faced clinical data quality, standardization, and project management issues in its R&D initiatives in ophthalmology. They worked with Maxis Clinical Sciences, an FSP that provided a team of 40 professionals with diverse skills. The team helped to manage clinical database design and management, statistical programming, and familiarity with CDISC standards. Maxis Clinical Sciences exceeded expectations, reducing the cycle time from protocol to study lock, allowing the company to concentrate on its research and planning. At the end of the 12-month engagement, Maxis Clinical Sciences completed the agreement, and the company continues to utilize Maxis as a value-added provider.

Visit this link to read more about this case study: Streamlining R&D with Functional Outsourcing

Case Study 2: A top 20 biopharmaceutical company faced capacity, knowledge, and expertise issues in executing a comprehensive clinical trials portfolio. Maxis Clinical Sciences provided a flexible and scalable FSP model solution by deploying a team of 20 seasoned clinical trial SMEs and therapeutic experts to facilitate high-quality drug development projects. Implementing the FSP model led to a 0% attrition rate among the clinical team, enabling the client to leverage subject matter expertise and strategic direction while outsourcing routine tasks to its CRO partner. The seamless integration of Maxis Clinical’s team allowed the client to address essential project tasks and scale their clinical development programs effectively.

Visit this link to read more about this case study: Maximizing Clinical Efficiency with FSP

Importance of FSP in Clinical Trials

Clinical trials are expensive and time-consuming endeavours that require careful planning and execution. The Tufts Center for the Study of Drug Development announced that it costs pharmaceutical companies $2.6 billion to develop a new drug. As such, effective FSP management is essential to ensure that clinical trials are conducted efficiently and cost-effectively.

One of the key factors in FSP management is stakeholder engagement. This effective stakeholder engagement which includes sponsors, investigators, CROs, and other service providers requires clear communication, collaboration, and a shared commitment to the trial’s completion.

In addition to stakeholder engagement, effective FSP management requires clear communication of expectations. This includes defining the scope of work, timelines, and quality standards for each FSP. According to an article published in the Journal of the American Board of Family Medicine, good communication and alignment of expectations between sponsors and FSP as key strategic criteria for clinical trials.

Timely decision-making is also essential for effective FSP management. Delays in decision-making can cause delays in the trial, leading to increased costs and lost revenue.

Finally, understanding the roles and responsibilities of each stakeholder is important key to effective FSP management. Each stakeholder has unique skills and responsibilities, and effective collaboration requires a clear understanding and communication of these roles.

Functional Service Providers (FSP) are an increasingly common component of clinical trials. FSP are third-party organizations that provide specialized services to clinical trials. These services include data management, statistical analysis, medical writing, regulatory consulting, and more. FSP are important because they help manage resources and timelines more efficiently and provide specialized expertise that may be outside the sponsor’s organization.

The use of FSP has become increasingly popular in recent years. This is because FSP can provide cost savings to sponsors. In addition to cost savings, FSP can also help to ensure that clinical trials are conducted in a safe and ethical manner. For example, FSP can provide regulatory expertise to help sponsors navigate complex regulations and guidelines. They can also help ensure that data is collected and analyzed to meet regulatory requirements and ethical standards.

Sponsors must ensure that FSP are adequately trained and clearly understand their roles and responsibilities. Communication between sponsors and FSP must be clear and timely to ensure that issues are addressed promptly. Additionally, sponsors must establish performance metrics to monitor the quality of services provided by FSP and to ensure that they are meeting expectations.

In summary, FSP are an important component of clinical trials, providing specialized services that help to ensure the safe and efficient completion of trials. By effectively managing FSP, sponsors can take advantage of cost savings while ensuring that trials are conducted in compliance with regulatory requirements and ethical standards.

FSP Services that are commonly used and how Maxis Clinical Sciences Provides Exceptional FSP Services to Improve Clinical Trials

Clinical Monitoring:

• Maxis Clinical Sciences Clinical Monitoring teams are highly trained and experienced in ensuring that clinical trials are conducted in compliance with protocols, regulations, and ethical principles. They are responsible for ensuring that data is collected accurately and completely, and that the trial is conducted in accordance with ethical principles.
• The experts visit trial sites regularly to review source documents, verify informed consent, and ensure that adverse events are reported appropriately.
• We also provide training and support to trial site staff and act as a liaison between the sponsor and the site, ensuring effective communication between all parties.

Data Management:

• Maxis Clinical Sciences’ data management teams are responsible for designing and developing case report forms (CRFs) to collect trial data. They ensure that the data is entered, validated, and cleaned accurately and in compliance with regulatory requirements.
• The teams conduct quality control and quality assurance checks on trial data to ensure that it is accurate, complete, and consistent. They use advanced data management tools and techniques to manage and analyze the data effectively.

Biostatistics:

• Maxis Clinical Sciences’ biostatisticians play a vital role in the design, analysis, and interpretation of clinical trial data. They work closely with clinical trial teams to develop statistical analysis plans and conduct statistical analyses, including sample size calculations, hypothesis testing, and modelling.
• They are highly experienced in designing and conducting complex statistical analyses and have a deep understanding of the regulatory requirements for clinical trial data analysis.

Medical Writing:

• Maxis Clinical Sciences’ medical writers are responsible for developing essential documents required for clinical trials, including clinical study reports (CSRs), protocols, and Investigational New Drug (IND) applications. They work closely with clinical trial teams and biostatisticians to ensure that trial data is accurately and clearly presented in these documents.
• They are experts in regulatory writing and have a deep understanding of regulatory guidelines and requirements. They ensure that all documents are well-written, scientifically sound, and comply with regulatory requirements.

Pharmacovigilance:

• Maxis Clinical Sciences’ pharmacovigilance team is responsible for monitoring the safety of investigational products throughout clinical trials and after they have been approved for use. They identify, evaluate, and report adverse events and develop risk management plans to minimize the potential for harm to trial participants.
• Maxis Clinical Sciences’ pharmacovigilance team has a deep understanding of safety regulations and requirements and works closely with clinical trial teams to ensure that safety data is accurately collected, analyzed, and reported in a timely manner.

Clinical Trial Supplies Management:

• Maxis Clinical Sciences’ clinical trial supplies management team manages the entire supply chain for investigational products, including forecasting, planning, packaging, labeling, distribution, and inventory management. •
• The team ensures that the right amount of investigational product is available at the right time and in the right place, reducing the likelihood of delays and ensuring that trials are conducted efficiently.

Regulatory Affairs:

• Maxis Clinical Sciences’ regulatory affairs team is responsible for ensuring that clinical trials are conducted in compliance with regulatory requirements. They prepare and submit regulatory documents, such as IND applications, Investigational Medicinal Product Dossiers (IMPDs), and Clinical Trial Authorization (CTA) applications, and work closely with regulatory authorities to obtain approvals and resolve issues.

The team has extensive experience in dealing with regulatory authorities and has a deep understanding of regulatory requirements. They ensure that all documents are prepared accurately and in compliance with regulatory guidelines and requirements, reducing the likelihood of delays and ensuring that trials are conducted efficiently.

The Key to Effective FSP Management in Clinical Trials

As mentioned earlier, the key to effective FSP management is to ensure that all stakeholders are informed, engaged, and working collaboratively towards a common goal. But what does that really mean? Let’s dive deeper into the key elements of effective FSP management.

• Choosing the Right FSP for the Clinical Trial

When selecting an FSP for a clinical trial, there are several factors to consider beyond just their expertise and experience in the relevant therapeutic area. Sponsors should also consider the FSP’s level of flexibility, ability to work collaboratively, and willingness to provide customized services. For example, if a sponsor requires a specialized service such as imaging or biomarker analysis, they may need to seek out an FSP with specific expertise in that area. Additionally, sponsors should consider the FSP’s track record for delivering quality work on time and within budget.

One example of an FSP with extensive experience in clinical trial management is Maxis Clinical Sciences, a global provider of advanced analytics, technology solutions, and clinical functional services. Maxis Clinical Sciences has a long history of working with sponsors across various therapeutic areas and is known for its ability to provide flexible and customized services to meet the unique needs of each trial.

• Best Practices for Clear Communication and Collaboration with FSP

Sponsors should establish a communication plan and identify key stakeholders and contact persons to ensure that everyone involved in the trial is aware of their roles and responsibilities. Regular check-ins and meetings with the FSP team can help monitor progress and ensure that the trial stays on track.

It’s also essential to communicate expectations, timelines, and deliverables clearly to the FSP team to avoid any confusion or misunderstandings. For example, if the sponsor requires specific data to be collected at a particular time point, they should communicate this clearly to the FSP team. This can help ensure that the FSP team is aware of the sponsor’s needs and can deliver quality work on time.

• Effective Project Management

Developing a detailed project plan with clear timelines, milestones, and deliverables can help ensure that the trial is conducted efficiently and effectively. It’s also essential to assign clear roles and responsibilities to the FSP team and establish processes for issue resolution.

Regular monitoring of progress and adjustment of the project plan as needed can help ensure that the trial stays on track. Additionally, FSP teams should be adequately trained in project management methodologies and tools to ensure that they can manage the trial effectively. For example, using project management software such as Microsoft Project can help FSP teams stay organized and on schedule.

• Data Management

Sponsors should ensure that the FSP team is equipped with the technology and tools to manage and track data accurately. Clear data standards, including data collection and analysis, should be established, and the FSP team should be trained in these standards and any relevant regulations and guidelines.

For example, the Clinical Data Interchange Standards Consortium (CDISC) provides standard data collection and analysis guidelines to help ensure that data collected during clinical trials can be analyzed and shared effectively. FSP teams should be familiar with CDISC standards and trained in their use to ensure that data is collected and analyzed consistently across all trials.

• Ensuring Proper Oversight and Quality Control

Sponsors should regularly monitor and audit the FSP to ensure that they are adhering to all regulatory requirements and ethical standards. Any issues or concerns that arise during the trial should be addressed promptly through established reporting requirements and escalation procedures.

For example, if a sponsor notices an issue with data quality, they should have a process in place for reporting this to the FSP team and escalating the issue if necessary. By ensuring proper oversight and quality control, sponsors can minimize the risk of errors and delays. It can also help ensure that the trial data is of high quality and can be used to support regulatory submissions and eventual drug approvals.

One approach to ensuring proper oversight and quality control is to establish a Clinical Trial Oversight Committee (CTOC) that includes representatives from both the sponsor and the FSP. The CTOC can be responsible for monitoring trial progress, identifying issues, and making recommendations for corrective action. The CTOC can also provide a forum for discussing trial performance metrics and identifying opportunities for improvement.

Another essential aspect of oversight and quality control is risk management. Sponsors and FSP should work together to identify potential risks to the trial’s success and develop mitigation strategies to address them. Risk management should be an ongoing process throughout the trial’s duration, with regular assessments of risk and the effectiveness of mitigation strategies.

Effective oversight and quality control also require robust reporting and escalation procedures. Sponsors should establish clear reporting requirements and escalation procedures for the FSP team to follow in the event of issues or concerns. These procedures should include a clear definition of what constitutes a significant issue or concern, who should be notified, and the timeline for reporting and resolution.

In addition to proper oversight and quality control, sponsors and FSP should prioritize patient safety and ethical conduct throughout the trial. This includes ensuring that all trial personnel are appropriately trained in patient safety and ethical conduct and that all trial activities adhere to applicable regulations and guidelines.

By following these best practices, sponsors can help ensure that their clinical trials are conducted ultimately leading to better patient outcomes.

Delivering the Benefits of Effective FSP Management in Clinical Trials to Clients

Improved trial efficiency and timelines: Effective FSP management involves clear communication and coordination between all stakeholders, which can expedite the clinical trial process. For example, FSP can provide expertise in data management, statistical analysis, medical writing, regulatory consulting, and more, which can lead to faster trial execution. Maxis Clinical Sciences’ FSP services help sponsors in effective trial management by providing customized solutions that cater to their specific needs. With a strong team of experts, Maxis ensures that communication is streamlined among all stakeholders and the trial process is expedited. Maxis provides expert services in data management, statistical analysis, medical writing, regulatory consulting, and more that help improve the trial efficiency and timelines.

Reduced risks and delays: Clinical trials are complex and involve multiple stakeholders, which can increase the risk of errors and delays. Effective FSP management can help to mitigate these risks by providing oversight and quality control throughout the trial. For example, sponsors can choose the right FSP for the trial and ensure that they have the necessary expertise and resources to conduct the trial. Maxis Clinical Sciences’ FSP services provide the necessary oversight and quality control throughout the trial to reduce the likelihood of errors and delays. Maxis ensures that the right team is deployed for each trial, with the necessary expertise and resources to conduct the trial efficiently.

Higher quality data: Effective FSP management ensures that data is collected, managed, and analyzed accurately and efficiently. FSP can provide specialized expertise in data management, statistical analysis, and other areas, which can result in higher-quality data. Maxis Clinical Sciences’ FSP services have a strong focus on data management, statistical analysis, and other areas that help to ensure high-quality data. Maxis ensures that the data collected is consistent and reliable, and the analysis is aligned with the study objectives.

Cost savings: Effective FSP management can result in cost savings for sponsors. FSP provide specialized services at a lower cost than would be possible if the clinical trial was conducted internally. By choosing the right FSP for the trial and ensuring that quality standards are met, sponsors can maximize cost savings while maintaining the quality of the trial. Maxis Clinical Sciences’ FSP services provide customized solutions that cater to the specific needs of each sponsor, helping to ensure cost savings while maintaining high-quality services. By outsourcing certain tasks to Maxis, sponsors can focus their internal resources on other critical aspects of the trial, further improving efficiency and cost-effectiveness.

By choosing the right FSP, communicating effectively and collaborating with them, and ensuring proper oversight and quality control, sponsors can reap significant benefits, such as improved efficiency and timelines, reduced risks and delays, higher quality data, and cost savings.

Therefore, we urge sponsors to implement best practices for FSP management in their clinical trials. By doing so, they can enhance the overall effectiveness of their clinical trials and contribute to the development of safe and effective medications for in-need patients.

As a leading Functional Service Provider in the pharmaceutical industry, Maxis Clinical Sciences offers a range of FSP services to help sponsors effectively manage their clinical trials. With our deep expertise in clinical trial management, data management, biostatistics, pharmacovigilance, and regulatory affairs, we help sponsors overcome the complex challenges of clinical development and bring life-saving therapies to market faster. At Maxis Clinical, we are committed to delivering quality results and ensuring timely completion of clinical trials. Our thought leadership and innovation in FSP services make us a trusted partner for sponsors looking to streamline their clinical trial operations and accelerate their drug development programs. Contact us today to learn more about our services and offerings.

Let us work together towards a common goal of improving healthcare through effective clinical trial management.

References:

Marino M, Jamal Z, Siccardi MA. Pharmaceutics. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 23, 2022. (https://www.ncbi.nlm.nih.gov/books/NBK535375/).

Bertram, Susan et al. “Communication is the key to success in pragmatic clinical trials in Practice-based Research Networks (PBRNs).” Journal of the American Board of Family Medicine : JABFM vol. 26,5 (2013): 571-8. doi:10.3122/jabfm.2013.05.120352 (https://pubmed.ncbi.nlm.nih.gov/24004709/).