Deciding Between a Large CRO and a Boutique CRO for Your Oncology Study

large cro and boutique croWhen it’s time to evaluate CROs for your oncology study, your first choice is typically to determine what type of CRO you are going to evaluate:

  • One of the handful of global CROs that dominate the top-end of the market
  • A boutique oncology CRO

There are benefits and detractions to both. In some situations, the large CRO is clearly going to be the best choice. In other situations … it might cause nothing but headaches, cost overruns, missed timelines and low-quality data.

Below are our recommendations on when it’s best to go with the large CRO, and when it’s best to go with the boutique CRO for your oncology study.

A Large CRO Might Be Best If You ….

Have a global trial in multiple continents.

Large CROs have a global reach and can often ramp up a global trial quickly. Most boutique CROs can’t. Therefore, a large global phase III trial may be best suited for the large CRO.

Are looking for a strategic partner who will take equity participation.

Most large CROs have been getting larger over the past few years.  This has led them to move beyond transactional services and create intricate deals with large drug makers, getting seats at R&D decision-making tables and equity participation.

Want a multi-year contract with a single provider for multiple studies.

Large sponsors are realizing that they can get more value from outsourcing by creating longer-term agreements, often over multiple therapeutic areas, with single providers.

Require a lot of PMs and CRAs quickly.

A common misconception is that large CROs have a large volume of people on the bench available to work on the next big trial that comes in the door. This is rarely true – having people on the bench hurts margins. Most CROs operate at similar margins, so the large CROs have to go out and staff up for a big trial just like the boutique CROs. But the scale and reach of the large CRO makes this easier for them.

A Boutique CRO Might Be Best if You …

Need the undivided attention of your CRO.

If you’re a small to midsize sponsor, or just starting with your oncology program, you may wish to have the undivided attention of your CRO in a partner-like model. Large global CROs get excited about large studies and big drug development deals, which sometimes causes smaller trials and smaller companies to get lost in the shuffle. It can be disheartening to watch your timelines and budgets continually growing without receiving an explanation from your CRO. While large CROs may present you with an “A” team in the bid defense, as a smaller company with a relatively small trial you may get a “C” team with little experience; at smaller CROs you often get an experienced “A” team that sees your trial through from site selection to delivery of results.

Want oncology expertise from all levels of people working on your trial.

Boutique CROs often have much lower turnover than large CROs, and can often identify the exact people to work on your trial. Oncology trials are complex, and there’s no substitute for experience at all levels. Your large CRO might have tremendous oncology experience as a company, but the CRA or the PM managing your trial may not. Check the credentials of the people assigned to your trial to make sure they have the experience you desire.

Need cost certainty.

Did you choose the large CRO because their initial bid was lower than the boutique CRO’s bid? This is common, but the change orders that inevitably come later will drive your cost up to a level usually much more than the smaller CRO. Verify the assumptions used in all bids and check the CRO’s policy on change orders before signing your MSA, regardless of what size CRO you’re working with.

Can’t afford extended timelines.

Turnover at CROs is high, and it’s common for large CROs to change your project manager mid-trial. This can extend your timelines as the new PM gets up to speed on your trial (possibly on your dime). The constant changing of CRAs and PMs can lead to frustrations at the site level as well.

Want to know exactly who is working on your trial.

Large CROs can mobilize a team quickly, but do you want to know who these people are? The ones who start your trial aren’t always the ones who deliver the final results. If you desire to have the same people working on your trial from start to finish, choose the boutique CRO (and confirm who will be working on you trial).

Are running a phase I or phase II.

Smaller oncology trials can be time-consuming just like larger trials, but they’re less profitable to the CRO. Phase I trials have different challenges than other phases, due to site selection, patient cohort management, DLTs, and small patient size. Boutique oncology CROs might be better suited to handle the nuances of these complex, lower profit trials.

As a boutique oncology CRO, we’ve seen every situation discussed above in the marketplace over the past 10 years. Having that big name CRO attached to your phase II trial for your single oncology drug may sound comforting, but the challenges that you could encounter might far outweigh the “name” benefit. We recommend that you take an objective look at your situation, the realities of the CRO marketplace, and what’s most important to your company during your study.

Then make the objective choice.