Communication is key in any complex project or organization, and this is especially true for clinical trials. A breakdown in communication between the people involved in clinical research – including the investigators, clinical research professionals, CRO, other vendors, participants and regulators – can be catastrophic, leading to delays, misalignment and increased risk.
Good communication is also foundational in making a CRO partnership work, and specifically in getting the most out of a Functional Service Provider (FSP) arrangement. An FSP partnership with a CRO can be a critical factor in streamlining operations and improving outcomes, giving the sponsor the flexibility, support and expertise they need at various points throughout the trial.
From clarifying roles to sharing successes, here are our top tips for strengthening communication as a foundation for an effective FSP partnership in clinical research.
Effective Communication Strategies with FSP Partners: Make Your Communication Clear from the Outset
Every successful relationship has an underlying layer of trust and transparency, and that is built by clear communication. The expectation can be set on both sides from the very first point of contact: the RFI or vendor selection process.
A sponsor could include clear communication in their requirements, outlining what they expect from the potential supplier. And they could demonstrate their expectations by communicating clearly throughout the selection process. This sets a precedent that can be carried throughout the relationship.
Vagueness and confusion about roles and responsibilities are sources of misunderstanding that can derail a partnership and negatively impact a clinical trial. At the start of an FSP partnership, it’s important to clearly set out roles and responsibilities, ultimately having these in writing to establish shared understanding. Each partner’s tasks and responsibilities should be agreed and written down, along with deliverables and a timeline that can be tracked in ongoing communication.
It’s also important to ensure clarity around shared goals, ranging from specific task-related deliverables to broader study goals. Aligning on these goals can happen through in-person or virtual meetings as well as in contracts and other paperwork related to the partnership. Again, this can be strengthened in the ongoing communication throughout the partnership. Alignment of the sponsor and CRO on goals can have a positive impact on timelines, quality and compliance.
Start the FSP Collaboration Way You Mean to Go On
If well established at the start of the FSP relationship, the communication approach chosen can be maintained easily throughout the clinical trial. There are a few ways to ensure this:
Invite openness: sponsors can encourage their FSP partners to share input and feedback, not only on the work being done but also on the communication itself. By listening to and, where relevant, acting on the information shared, the sponsor can strengthen two-way communication. Similarly, sharing feedback and providing the CRO with input, and acknowledging action or responses, can foster good communication.
Share challenges: rather than waiting for the seed of a problem to grow into something that requires escalation, share challenges as soon as they emerge. Taking this a step further, talk openly about risks that might arise and agree on ways to mitigate them before they become problems. At the same time, ensure there is an effective and agreed escalation process in place.
Plan for progress: ensure there are milestones set out on your partnership’s path so you can check in and discuss progress. At these points, it’s helpful to think about not just performance and deliverables but also the partnership more broadly, including communication.
Keep Communicating Throughout the Partnership
An FSP partnership between a sponsor and CRO can feel more ‘hands-off’ than a full-service arrangement because the sponsor retains day-to-day control and management of the clinical trial. It might therefore be easier to let regular communication slide. However, this can have a detrimental effect, not only on the work being done but also on the partnership itself.
Rather than relying on natural points of communication, consider scheduling contact moments for various purposes and between different people. For example, after a kickoff meeting, schedule regular check-ins between fixed contact people on both sides. This might be weekly phone calls or monthly virtual meetings, depending on the need and the tasks being fulfilled. In addition to this, milestones set out at the start of the partnership could be marked with a meeting, to review the work and communication between parties.
With these regular and pre-determined points of contact, the risk of problems needing escalation is reduced. It also means adjustments to the arrangement are easier to make, while ensuring the study stays on track. In this way, good communication enables a sponsor to get the most benefit from the flexibility inherent to FSP models.
Adapt Communication Tools and Approaches
When to communicate is important, as it can keep the work and the relationship on track. Equally important is how to communicate. If the method of communication chosen for a certain purpose is unfamiliar or uncomfortable to one of the parties involved, it could mean communication falls by the wayside.
First consider what tools and methods are part of the team’s everyday work. If the sponsor works with Microsoft Teams and SharePoint, for example, it makes sense to continue using those channels, if possible, rather than try to set up something new for the partnership. Factor in time for getting the CRO and the people joining the team on an FSP basis connected and familiarized with the technology.
When choosing tools, think about regular meetings, everyday communication, and document sharing and storage.
It’s also worth thinking about communication styles and preferences, and clearly communicating with the people involved if there are any expectations around this. If the trial is international, time zones might be a consideration – a good starting point could be establishing core hours that everyone should be available.
Leveraging Good Communication in FSP Partnerships
Effective Communication Strategies with FSP Partners: Clear, effective communication is the foundation for a successful FSP partnership in clinical research. It not only helps the sponsor ensure the tasks being covered are completed to a high degree of quality and on time, but it also unlocks the benefits of flexibility and adaptability that the FSP model can bring.
FSP in clinical research can give you the flexibility you need to succeed. With Siron Clinical, you can build a foundation of effective communication to help you unlock all the benefits of the FSP model. Find out more and get in touch.
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