October 20, 2020

Selecting a CRO: Considerations for Small to Mid-Sized Sponsors

Selecting a CRO is a big decision that may have a large impact on your study’s chances of success. Is the “big box” CRO your safest bet?

Let’s say you work at a small biotech company that has decided to partner with a big name, big box CRO for an upcoming trial. You’ve been thoroughly impressed by the team you met with. They’re at one of the most well-known CROs in the industry, and highly experienced. You feel your project will absolutely benefit from their significant study-specific expertise.

You sign a contract with them, and a start-up period commences.

The CRO leadership team that had impressed you so much begins by introducing you to the less experienced staff that will actually be organizing the project.

Sure, it’s not ideal—but things start off smoothly.

As time goes by, you find that more and more responsibilities are being passed off to less and less experienced team members.

You notice timelines are extending, but you aren’t getting any real reason as to why from the CRO.

Are the experts you were initially sold on even involved in your study at all?

As a smaller sponsor working with a big name, “big-box” CRO, there are a few pitfalls to watch out for.

While the company may have experience in your study’s therapeutic area, the actual people who are managing your study may not—and this difference is critical.

If you’re considering selecting a big name CRO, remember that the “A” team has little to no involvement in a smaller study’s operations or success—that team is reserved for large pharmaceutical companies with whom a large portion of the CRO’s revenue is generated.

Without a doubt, “A team” members and “niche experts” are huge selling points.

But just because you meet them in a sales pitch doesn’t mean you’ll be able to reap the benefits of having access to one. Be sure to ask directly: “How is this person going to be involved in study operations?”

Fan of surprises? What about surprise costs?

Unfortunately, certain large CROs are often notorious for tacking on fees for services you didn’t know you had agreed to, after they’ve already been completed.

Yes: certain factors sometimes arise during a study that require an expansion of the current scope of work. But ANY changes that may affect cost (or timelines) should be fully and openly discussed between teams.

Large, big name CROs get more excited about large studies and huge drug development deals. This leaves smaller trials and clients feeling “lost in the shuffle.”

Sponsors may notice timelines and budget start to grow without explanation from their CRO as they’re repeatedly pushed to the back of the line.

Additionally, large CROs will not have the same flexibility that small to mid size CROs hold. If something unexpected arises, expect delays. A big box provider will likely have layers of middle men to go through before meaningful solutions can be internally approved, much less initiated.

About PharPoint Research:

PharPoint is a right-sized, client-focused, and award-winning CRO that works with sponsors of all sizes to improve global health. Interested in setting up a time to talk with our team?

Why PharPoint: Our Values in Action

Ann Trace, BS, ME, Joins PharPoint as Director of QA