What To Look For In A CRO: Expertise, Infrastructure, Communication

By Ed Miseta, Chief Editor, Clinical Leader

When he decided to start a CRO four years ago, Renold Capocasale, founder and CEO of FlowMetric, decided talent and expertise would be the best way to differentiate his company from competitors. A former pharma employee himself, Capocasale immediately set out to hire scientists with a background in pharma. He uses the background of those employees to sell clients on the topics of quality and timeliness, something near and dear to their hearts. The company is already profitable, and recently opened a second office in Milan, Italy.

I recently spoke with him on what sponsors should look for when selecting a CRO partner. 

Ed Miseta: The industry seems to be evolving from transactional relationships to more strategic ones. If we want a closer relationship, where both sponsor and CRO will be more successful, what should sponsors look for when selecting a CRO partner?

Renold Capocasale, founder and CEO, FlowMetric

Renold Capocasale: First and foremost, decision makers at pharma companies must do their best to truly understand the expertise of the partners they select. I advise sponsors to ensure any potential partner has the expertise to perform the tasks you are asking them to complete. That must always be the number one consideration.  

After that, make sure they have the infrastructure and the logistical bandwidth to perform what you have asked them to perform. Is it physically impossible for them to deliver on a specific date for any reason? If you see any red flags at all, that should tell you they may not be the right selection, regardless of the price they have quoted.

Miseta: If you are performing an oncology study, it would not be difficult to determine if a CRO has expertise in that area. They should be able to point to studies they have performed or the capabilities of staff members. However, it seems like it would be more difficult to determine infrastructure and bandwidth. How do you recommend they do that?

Capocasale: There's certainly due diligence that would have to be done. I strongly advise all of our potential clients to come visit us. That is also a good time to help the sponsor fully understand your capabilities. I like to note that we are not an emergency room. You can’t expect to call a CRO on Friday and say you need a study done the next Thursday. These projects cannot happen that way.

But generally the individual or committee making the outsourcing decision will have the time afforded to them to go out and visit the CRO. This provides the opportunity to view their quality standards and to experience the culture in the company firsthand. Always do an audit and perform all the checks that need to be done. Never rely on hearsay to determine if a company has good laboratory practice. You have to go and check. But once a sponsor can see the quality of your infrastructure and the quality of what the CRO can offer, price becomes almost inconsequential.

Miseta: But that’s provided all the quotes are in the same ballpark?

Capocasale: Exactly. Most quotes will be similar. If any are way out of line they can be discarded. Then the focus can be on timeliness, regulatory, and other factors that are more important to you. These factors should help you make an informed decision that will lead to success. 

Then lastly, the success of the project will come down to relationships. Once you've engaged with a partner, how is the relationship proceeding? Do you have someone who is communicative? Obviously, the more the two sides communicate the better. In person meetings are always better, but any kind of communication is better than none at all.

I would recommend that sponsors be in the know about everything the CRO is doing for you. Is the sponsor paying for all the work performed, or is the CRO sometimes going the extra mile for you? I find many CROs are overworked because they are trying to be everything for everyone. CROs can’t do that if they want to truly be experts and not allow their quality standards to suffer.

I believe the clinical space is a big enough pie that everyone can co-survive in it, regardless of company size. Large CROs are clearly doing well, but smaller niche CROs fill a very specific role as well. I predict we will see a lot more of that in the years to come.