BY SKIP SANDS, MD - SENIOR VICE PRESIDENT AND SENIOR MEDICAL OFFICER, PAREXEL Biotech
During the twenty years I served as a chief medical officer for small and emerging biotech firms, selecting the right contract research organization (CRO) was one of the most important decisions I made. I quickly learned that it wasn’t enough to hire CROs with the resources to execute our development plan. They also needed to have the knowledge and expertise to optimize that plan, particularly in helping us avoid missteps and delays.
This required evaluating their soft skills just as much as their technical ones. Are they transparent? Are they flexible? Are they easy to communicate with? Even when the answers to those questions were yes, I found it helpful to establish some ground rules for working together to avoid the misalignments and misunderstandings that often cause these relationships to run off track. Doing so requires the following three steps:
1. Start with a detailed communication plan.
The first step is to create a communication plan that lists what will be delivered and when with mutually agreed-upon dates. When establishing those plans, it’s essential to address questions like:
- How quickly will emails be answered?
- What’s the standard turn-around time for documents?
- What’s the definition of “urgent”? And what’s the response time for emails and documents that qualify as such? (This is harder to define than you’d think.)
- How will we handle document version control? (This may sound basic, but it can quickly create fiascos unless it’s spelled out.)
The communication plan should also specify how you’ll deal with miscommunications, the escalation process for solving problems, and whether you’ll retain the team if there’s a significant delay in a clinical trial. This process might sound like a lot of work, but it will open communication channels in a way that enables you to ask for what you want and for CROs to provide their best advice on how to achieve it.
For example, a Parexel client recently asked us to conduct a feasibility study for selecting global sites for an upcoming trial. After we identified the top 20 countries that would facilitate enrollment, they asked us to add a country site that was far down our list because of high start-up costs and limitations in patient enrollment. The request was confusing until we realized they had goals that went beyond the trial, such as working with a key opinion leader who had advocated for their compound and was part of their future marketing plan. Once we understood why they wanted to add the site, we devised a cost-effective way to include it. The clear communication we’d established early on allowed us to resolve the issue quickly.
2. Look for CRO staff who fit your company’s culture.
When there’s a good culture fit between your firm and the CRO, you end up with an empowered project team. I’ve seen cases where the combined company-CRO team worked so well together that they regularly and eagerly worked overtime to beat deadlines. Of course, it also helps if the CRO team has streamlined processes and a flat organizational structure.
When assembling a company-CRO team, some things to consider are whether the CRO staff has temperaments and work styles that work well with yours. Is one side more dogmatic or directive? How eager are they to collaborate? Are these people who can offer us good advice and strong direction as we execute this trial?
Some CRO cultures are more hierarchical than others, so it’s worth thinking about how that will play out as you work together on projects. And if the CRO staff you’ve been offered doesn’t gel with your team, don’t be afraid to request a change. You may never find a perfect fit, but it’s worth trying to find one that’s good enough.
3. Leave nothing unsaid.
It’s often the things you don’t say in relationships that cause the most problems, and contractual ones are no different. So it’s worth taking the time to imagine possible scenarios and specify in the contract how they’ll be addressed. For example, what if you have to drastically change the original plan or scope of the development program mid-stream? Will the CRO be able to swiftly shift additional resources to your project if needed?
It’s also critical to do your homework when proposing contract language so you can establish accurate timelines that account for complying with local rules. For example, the chief financial officer of an APAC-based client company was under pressure from senior management and investors to accelerate the start-up time for a clinical trial in the United States. But because of tight rules on getting institutional review board (IRB) and ethics committee approvals, the process couldn’t be accelerated. The impact of these requirements on the trial timing hadn’t been addressed in the contract, and the CFO, unfamiliar with U.S. trial procedures, wasn’t happy about the unwelcome surprise. This could have been avoided if the contract had specified that the timeline was based on strict local rules.
Along these lines, plans for communicating with sites should specify who will do what to avoid duplication and annoying site staff. It’s counterproductive for five people from your firm and the CRO to call a site to request the same document. So be sure to specify one point of contact for every site. Taking this precaution, as well as the others I’ve mentioned, will lead to better results.
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