Congratulations! You’ve just selected the contract research organization (CRO) that best fits your goals, timeline, budget and philosophy. You’re confident that the project team, study and company will be successful! What’s next? Whether you are expecting a “turn-key” solution from your chosen CRO or are partnering with them for a portion of a larger project, there are some important considerations to explore to ensure a collaborative relationship and an outstanding clinical project.
Having worked on both the sponsor and CRO sides, I have a few tips to share regarding how you, as a sponsor, can get off to the best start possible, maintain a strong working relationship with your chosen CRO and ultimately run a successful study.
Establish clear roles and responsibilities early
Once the dust has settled and the contract and work orders are signed, the first order of business with your CRO is to confirm and document the roles and responsibilities of each party in detail. A kick-off meeting with your CRO is the perfect time to do this. Questions to ask include:
Who is driving the project, thinking proactively, anticipating next challenges and proposing next steps?
Who will be leading team meetings and issuing meeting minutes and action items?
Who is responsible for driving the completion of action items?
Who is responsible for ensuring enrollment is on track?
This is the time to set very clear expectations. It’s not just about defining roles and responsibilities; it’s also the time to discuss in detail how responsibilities will be fulfilled.
Allocate appropriate sponsor resources to manage the CRO
Ensure that your upper management does not underestimate resource needs from the sponsor side. It’s a mistake to think that it’s “all in the CRO’s hands” and that few to no sponsor resources are needed. There is a balance between micromanaging your CRO and taking a totally hands-off approach. The right balance comes from the CRO and the sponsor being comfortable with the established roles and responsibilities and trusting each other to independently perform as agreed. Ensuring that you, as the sponsor, have a dedicated resource to work with the CRO is vital to the success of your project.
Hold the CRO accountable and voice your concerns early
Once the sponsor and CRO have established clear roles and responsibilities, it’s important for the sponsor to hold the CRO accountable. Some questions to ask yourself include:
Is the CRO performing as you expected? Meeting timelines? Staying within budget?
Is the quality of the CRO deliverables up to your company’s standards?
Do your sites enjoy working with the CRO staff? If not, do you understand why?
Have there been changes in the scope of work?
Have expectations been made clear?
If you, as the sponsor, are not satisfied with any aspect of the CRO’s performance, no matter how small it may seem, don’t hesitate to voice your concerns. The earlier issues are addressed the better! Resist the urge to just fix it yourself. It is your responsibility to ensure that you understand the situation and provide constructive, relevant and timely feedback to your CRO.
Communicate, communicate and communicate some more!
As with any relationship, clear and frequent communication is the key to a productive, collaborative and effective sponsor-CRO partnership. Establish your preferred method of communication at the start and be willing to adjust as challenges and opportunities arise. Be clear about what and when to communicate and how to communicate, i.e., via phone call, meeting or email.
Implementing these simple tips can help ensure that you have a positive relationship with your CRO, which is the foundation for a successful clinical study.