CRO selection can sometimes be difficult to navigate. “My favorite meeting to have with a CRO is the one where I get to fire them.” Our client was only half-joking when he said this, as a way to illustrate how difficult it was to find the right CRO to tackle his projects. The first problem is CROs who primarily work with pharma trials and don’t understand the nuances of medical devices. Available resources can be a concern with small companies, so it seems like a big company with a big name is a safer bet. But there are drawbacks that can make the big companies challenging to work with, sometimes to the detriment of project outcomes. For example, this client cited a revolving door of project managers over the course of his clinical studies. Larger companies also tend to have more siloed operations, which can lead to a checklist mentality as opposed to a thoughtful, holistic approach to a project’s needs.
Of course it is ideal to find a CRO with experience in the particular product type and therapeutic area of interest, but as important is to find a CRO with the knowledge and experience to apply the appropriate regulations and international standards and to tailor the project to the specific needs of your product and company goals. Ask yourself whether they are listening to your needs and have the flexibility to create a customized program to meet those needs in an efficient and cost-effective way, or if they are just trying to fit your project into their clinical trial machine. Will they be attentive and devote resources even on smaller projects? For the best chance at success (and the best experience), the CRO must be proactive and responsive. They must identify any potential study issues and have the ability to course correct and implement changes quickly, and the project team must be available to answer questions and provide updates as often as desired.
There is another mid-sized CRO with whom we’ve worked on various projects over the past 20 years, and we were talking recently about the challenges for sponsors in finding the right-sized CRO with the right expertise to help them get to the finish line.
Using site selection as an example, they mentioned that larger CROs usually have a team of people that assess sites, a different team of people that select the sites, and still another team of people that initiate the sites–and that is all before the first patient is even enrolled. It doesn’t take long to see that this approach can lead to inconsistencies, loss of critical information through the various transfers, and perhaps most drastically, the costs adding up exponentially.
Over the years they have received many calls from clients who had opted for a large, well-known CRO only to find themselves mid-study looking to make a change because they were so dissatisfied with their experience.
On the other hand, they said while large CROs can sometimes be less approachable and inflexible, there is also a danger in hiring a CRO that is too specialized. They may have a limited scope when you need full-service support. For instance, can they assist with data management? Will they help you recruit and manage safety boards or committees? Will they be able to conduct audits to help you prepare to pass BIMO FDA inspections? Can they provide general site support and project management help in addition to clinical monitoring?
Perhaps most importantly, in addition to expertise in clinical trial operations, try to get a feel for what the experience will be like working with a CRO. Are they responsive and willing to work with you and communicate throughout the project? Do they have high turnover in project teams? These are all important factors to consider on your quest to find the right CRO.
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