How to Maintain Quality and Compliance with FSPs: Quality and compliance are key to success in clinical research, and as such, they should be central considerations in the partnership between a sponsor and CRO, including on a Functional Service Provider (FSP) basis.
Considering the differences between full-service and FSP agreements, and the role of the sponsor in each case, how can biotechs and pharmaceutical companies ensure they maintain high quality and remain compliant throughout the clinical trial when engaging in an FSP contract?
In this blog post, we look at three of the main things to consider for quality and compliance of a clinical trial conducted with FSP support from a CRO.
What is FSP in clinical research?
Clinical research partnerships, particularly between sponsor and CRO, are becoming more flexible in response to the growing need for adaptability in the dynamic clinical research landscape. Traditionally, the full-service CRO partnership involved the CRO taking on the overall running of the clinical trial. In contrast, a Functional Service Provider (FSP) model involves a clinical research sponsor outsourcing specific functions to the CRO. In this model, the sponsor is in control of the clinical trial and any data generated.
According to a 2024 report by InsightAce Analytic, the global FSP market is expected to reach a value of US$29.62 bn by 2031. As it rises in popularity, the FSP approach is also changing. Early models focused on recruitment of individual FTEs for clinical monitoring, with the sponsor paying the provider for the FTEs needed. This has broadened to meet the changing needs of biotechs, and a range of tasks and functions can now be included in an FSP agreement, as is the case for Siron Clinical.
In addition to benefits such as cost-effectiveness, improved efficiency and greater flexibility, FSP can also contribute to maintaining quality and ensuring compliance with relevant guidelines and regulations.
Tip 1: Set Out Clear Responsibilities with Effective Governance
However extensive the agreement between sponsor and CRO is, it’s important to be clear about roles and responsibilities, and to establish a robust governance system. Not only is this required for compliance, but it also helps strengthen the trial process, improve efficiency, and ensure any problems are addressed quickly.
Sponsors are required by regulation, including from the EMA and FDA, to have ultimate oversight of clinical trial conduct and compliance, even if they are outsourcing services to a partner. The FSP model is beneficial here, as sponsors retain not just oversight but also control of the trial conduct and ownership of any resulting data.
Beyond this overarching oversight and control, it’s useful for sponsors and CROs to have a governance structure in place that clearly sets out escalation paths, so that any arising issues can be addressed effectively, thereby maintaining quality and compliance in areas like patient safety. The governance approach could be set out in the contract or in related documentation and supported by regular communication points.
Tip 2: Plan for Proactive Communication
Good communication from the outset can help embed a culture of quality and ensure compliance in the sponsor–CRO partnership. This comes down partly to the fit of the relationship and partly the design of the interaction. But it doesn’t have to be left to chance: you can plan good communication.
When choosing a CRO partner for a clinical trial, it’s important to choose a partner you can communicate with well. Even if you are confident there is good communication between the parties, it is helpful to put structures and processes in place that make it second-nature.
For example, set up regular contact points for different purposes, as needed, such as a weekly progress update and monthly performance check. Consider the reasons for communication when determining these – like task completion, performance against targets, timeline adherence or simply relationship maintenance – and agree on goals for each meeting.
Beyond these regular contact points, processes connected with the governance structure can dictate when and how to communicate about an issue that has been escalated, for example. With these processes in place, ensure there is also flexibility and incorporate risk management where necessary, such as by appointing secondary people for issue resolution in case of absence.
Tip 3: Use the CRO’s Expertise and Tools
As we outlined in a previous blog post, an FSP arrangement that’s tailored to your needs can help you increase the efficiency of your operations while maintaining quality. This is partly due to the flexibility FSP offers: you can adjust your requirements as the trial progresses, ensuring you always meet its needs.
This might mean engaging the services of a compliance expert at some point during the trial – and that’s something to consider when searching for a CRO to partner with. Some CROs have expertise in areas like compliance and quality assurance, making it easier to benefit from that as and when you need to.
Finally, technology can help you ensure compliance and maintain quality. For example, you may be able to choose a CRO that can provide an effective eTMF solution alongside your FSP requirements.
At Siron Clinical, we understand your need for high-quality data and compliant operations, and our experts know how to support you throughout the trial. Our Customizable FSP model provides the specialist expertise you need to succeed. Find out more here.
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