When a sponsor works with a CRO, they’re looking to bring expertise into their team. But what impact does the type of contract – full-service or FSP – have on this, and how can sponsors get the most out of the CRO’s expertise?
For a small biotech or pharma company, a clinical trial can be a daunting undertaking. Partnering with a CRO can help these sponsors by providing the professionals they need to successfully navigate the process. In particular, people with the right experience and expertise can help drive the trial to a successful outcome.
Some of the challenges sponsors face are related to the fast-changing nature of clinical research, and the need for agility and flexibility. This is one of the reasons the functional service provider (FSP) model is becoming increasingly popular. A sponsor can choose to work with a CRO on a full-service or FSP basis, and this decision can have an impact on the expertise they are adding to their clinical trial.
In this blog post, we look at why expertise is a critical element of a CRO–sponsor partnership, especially when it’s an FSP agreement. We explore the different aspects of expertise to consider, how to leverage that expertise, and why FSP is ideal for bringing experts into your clinical trial team.
The Impact of Expertise in FSP Sponsor–CRO Partnerships
Although CRO expertise is important in any sponsor–CRO partnership, it is fundamental and often more accessible in an FSP arrangement. It is common for large and international CROs to assign more junior staff to their full-service clinical trial contracts, leaving the more experienced or senior professionals to work on FSP contracts.
This gives the CRO more flexibility with their own in-house expertise, but it limits sponsors’ access to those experts on a day-to-day basis in many full-service partnerships. But it’s this flexibility that makes FSP projects more likely to be assigned to senior professionals and those with greater expertise.
On the sponsor side, an FSP agreement strengthens the team and the sponsor’s capabilities as needed, without the need to hire full-time employees. Working with more experienced CRO professionals also brings greater efficiency to the sponsor team, potentially with faster start-up timelines and a smoother path to market.
Types of Expertise in a CRO Partnership
In a sponsor–CRO FSP partnership, expertise is a key element in several areas.
- In general, the professionals a sponsor will work with on the CRO side will have expertise related to the specific tasks and responsibilities they are given – for example, in clinical monitoring or data management.
- Stepping back for a broader view, individual professionals or the CRO as a whole might have expertise in particular therapeutic areas, such as oncology or cardiology.
- And whether or not the sponsor has engaged the CRO to handle compliance and regulation, the CRO’s expertise in this area may also play an important role.
Leverage FSP expertise: to get the most out of your access to a CRO’s expertise, when shaping the partnership consider all three of these areas and map out where and when you could best use the expertise in the clinical trial. Focusing on risk can help clarify this and ensure long-term stability for the duration of the trial.
1: Task-Related Expertise in FSP Clinical Research
In an FSP partnership, the sponsor can define the tasks and responsibilities for which they need support. At Siron Clinical, that means the sponsor gets our expertise on their terms. We provide specialist expertise and fulfill specific tasks and functions the sponsor needs at every stage of the clinical trial.
Some of the most commonly requested tasks include:
- Regulatory submissions
- Clinical monitoring
- Project training
- Project management
- Patient recruitment and retention
In an FSP partnership, the CRO expertise is delivered according to the sponsor’s changing needs, rather than the CRO’s capacity. This means the service changes with the trial, and the sponsor retains control.
2: Therapeutic Area Expertise in FSP Partnerships
When a sponsor works with a CRO on a full-service basis, it’s likely that therapeutic area expertise at the organizational level will be among the criteria for selection. Despite the many similarities, clinical trials in different therapeutic areas can encounter unique challenges that require the right expertise to tackle.
Although a sponsor may be more focused about the tasks needing to be fulfilled in an FSP contract, having that therapeutic expertise at the individual level as well as the organizational level can add a depth of expertise that helps the trial run smoothly.
For example, oncology clinical trials can be highly complex and have the potential to save millions of lives. Cardiovascular studies can be large and involve multiple sites across various countries, while trials for orphan indications are likely much more focused, with smaller patient populations and more recruitment challenges. And although there are similarities with drug trials, medical device clinical trials also involve a different set of regulatory considerations and unique challenges.
3: Ensuring Compliance with Expertise in FSP
CRO expertise can support compliance and mitigate risk both directly and indirectly in an FSP CRO partnership. Directly, it’s beneficial for the sponsor to leverage the CRO’s in-house compliance and risk management expertise as and when they need it during the clinical trial. This might mean engaging a regulatory specialist during trial design and submission, to manage governance, and to ensure successful completion.
Compliance and quality management are connected to every aspect of a clinical trial, so whether the experts are working on patient recruitment or clinical monitoring, data management or regulatory submission, they will need a certain amount of expertise. Compliance expertise helps ensure that whatever the tasks being fulfilled, the professionals the sponsor works with understand how to maintain inspection-ready records, for example.
More indirectly, FSP partnerships support sponsor oversight and thereby compliance. Today’s clinical trial regulations, both in Europe and the USA, require sponsors to retain ultimate oversight of the conduct and compliance of the clinical trial, regardless of who carries out the tasks. This can be more challenging in a full-service CRO partnership, as the sponsor has less insight into the day-to-day operations. However, in an FSP partnership, the sponsor retains total control and oversight while tasks are completed by the CRO representatives.
How to Maximize CRO Expertise in Your FSP Clinical Trial
In an FSP partnership between a CRO and sponsor, there are several ways both parties can maximize the positive impact of the CRO’s expertise on the clinical trial.
- Weave the expertise needed into the selection criteria – from the outset, the sponsor can be clear about the specific task-related expertise and therapeutic area expertise they are looking for, helping the CRO identify whether they can fulfil those needs.
- Build a strong FSP partnership from the start – a positive partnership is built on a strong governance structure with clear processes and paths of escalation that both parties agree on. With a solid foundation, the expertise can be optimally applied.
- Communicate effectively throughout the trial – both at structured and planned points of communication, such as weekly check-ins and monthly meetings, and when concerns need to be flagged or additional expertise requested.
- Support knowledge transfer – the CRO’s expertise doesn’t just benefit the clinical trial in the moment. If knowledge transfer is planned and implemented, that expertise can have a lasting impact on the clinical trial and the sponsor organization.
The Importance of Expertise in Clinical Research FSPs
FSP sponsor–CRO partnerships rely on various types of expertise to ensure the success of the clinical trial. Central to the success of Siron Clinical’s flexible FSP contracts is the skill of our CRAs and project managers. Each of our CRAs in clinical research has experience of at least 15 years, and their therapeutic expertise has been applied across a range of trial types. Find out more here.
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