September 28, 2016. San Diego, California
Program organized and sponsored by PRC Clinical
Report by Dr. Roberta Alexander
ClinPulse is an expert panel and networking event series organized by PRC Clinical. Most of the ClinPulse events are held in the San Francisco Bay area, as PRC is headquartered in San Bruno, CA, but on September 28, 2016, PRC came down to SoCal. The San Diego event took place at the Sanford Institute for Regenerative Medicine, and was a great networking and learning opportunity. The panelists were Mary Syto, Director of Clinical Operations at Receptos; Teri Hicks, Director, Clinical Data Management at Statistics and Data Corporation (SDC); and Sue Dowden, Senior Director Clinical Operations, PRC Clinical. All the panelists have extensive experience in clinical research. Teri’s perspective focused mainly on data management and biostatistics, while Sue and Mary’s experience lies mainly in clinical operations. The discussion was moderated by Jennifer Reichuber, Founder + Principal at Altani Associates.
What are the tips and tricks for a successful interaction between CRO and Sponsor?
Not surprisingly, the most important aspect of any good relationship is clear communication and transparency. A face-to-face kickoff meeting is very important, not only to discuss the project, the expectations, and the roles and the responsibilities of the team members, but also to build personal relationships. Personal interaction facilitates trust and understanding. A social event the night before the kick off meeting is useful in building camaraderie. The kickoff meeting is a good opportunity to lay out the expectations. As a sponsor, don’t assume that the CRO’s clinical operation team knows the terms of the contract. Understanding who the team members are, their experience, and their role in the project helps in building a successful team. Everyone at the kickoff meeting should introduce themselves by briefly describing their background, expertise, and role in the project. Weekly meetings are a good strategy to touch base. Often, it’s not necessary to set an agenda, because what is most important is just to talk and share thoughts. These weekly meetings are especially productive if they are conducted one-on-one with your counterpart in the project — too many people talking simultaneously on the telephone could make effective communication difficult.
Understand the communication style of your partner. People who prefer to email because they want to keep a record of everything may get frustrated if they don’t receive a response quickly. Instead of getting frustrated, it may be more productive for these people to simply pick up the telephone.
In terms of transparency, the CRO may find it useful to know that the sponsor has a board meeting or an investor meeting coming up — they will better understand the needs of the company. After all, both sponsor and CRO have the common goal of delivering a successful clinical program and, as such, should each subscribe to the following sentiment, “It’s not my team or your team, but our team!” In addition, the CRO often brings valuable expertise. Sponsors should not view the CRO as somebody who works for them and has to do things their way, but, rather, as a partner who could contribute valuable insight.
The CRO needs to share the enthusiasm of the sponsor. While this may seem obvious, it’s important that the sponsor’s representative is passionate about the product and study protocol, and communicates this enthusiasm during protocol training. A company may work with multiple CROs during the same project, and different vendors may need to interact with one another. It may be useful if the CROs interact directly. Of course, the sponsor needs to agree to this type of direct communication; however, it could be beneficial for all the parties involved.
How do you select the CRO that best fits your needs?
A large CRO may not necessarily make sense for a big study. Although it may seem easier to work with one CRO and one contract, it may not always be the best solution. Small CROs are often functional CROs. Although they have experience in a particular area, but not another, this should not be viewed as a weakness. For example, SDC focuses on data management, and it partners often with PRC Clinical when clinical operations are concerned.
What are the warning signs that something is going wrong?
Lack of engagement, lack of communication, and not meeting deadlines are potential red flags. On the other hand, some difficulties in the study may simply be due to a difficult therapeutic area, or strict inclusion and exclusion criteria that make enrollment slow. In any case, make sure everyone is clear about deadlines. Deadlines are not necessarily dates, but how many months are needed to accomplish a certain deliverable.
Can you fire the CRO?
Yes, you can, but be sure you understand the consequences. For example, if the sponsor owns the electronic data capture (EDC) tools, the second CRO can jump in relatively easily. On the other hand, if you are close to data lock, it may just be easier and cheaper to stay the course. Keep in mind that moving data from one EDC system to another may not be straightforward, and you may have to maintain both EDCs for regulatory purposes.
The attendees enjoyed the networking and actively participated in the discussion. We look forward to the next ClinPulse event in San Diego!