CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Mike Jagielski, CEO of the Berlin-based CRO KCR (Knowledge Commitment Results).

Q: You have advocated for a change in the fee structures for CROs. Why do you think this makes sense?

A: There’s a lot of pressure on the CRO industry to be more effective and faster—to be innovative. When you look around, who are the most innovative companies? It’s the software companies. If they don’t constantly come out with exciting new in­novations, they will die out fast. When you look at software, you know that many hours of work went into it, but you don’t pay for those hours. You pay a licensing fee for the software and for the in­novation. If you need a software company to adapt innovation to meet your exact needs, you can buy a license for that as well.

When CROs take on a new client, they adapt their already-existing systems to develop an elaborate execution platform for the biopharma company’s trials. Yet we as CROs aren’t directly able to charge for that. Instead we charge for hours worked once the system is ready. But why are those innovations that different that from, say, buying software, where you pay for what the product is worth rather than paying for the exact hours worked? Companies are used to paying us for billable hours, and not for inno­vation, yet they want innovation from us.

It’s not an easy conversation to have, but I’m optimistic. With more technologies mak­ing their way into clinical research execution, I hope pharma will be increasingly open to discussing various business models. In the end we as CROs have to drive innovation, and that’s very hard to do when trapped in a fee-for-service model.

Q: You have said that it is ideal for CROs to grow bigger but stay as agile as a small CRO. How exactly can a CRO manage that?

A: That’s the million dollar question right now. If you are a large company handling large clients who want to conduct large trials all over the world, that’s fantastic, but it comes at the cost of agility. You can’t suddenly redirect a ship of 5,000 people overnight.

The way I look at it, there are two ways to grow bigger—by hiring more people or by making your procedures more efficient so you can do more work with the same amount of people. It’s about being innova­tive. This is just necessary now.

Research and development in general is getting more complicated. Sponsors often need to make a change—maybe a standard protocol amendment or a change to eligibili­ty criteria—and they have to do it fast. Large companies can do that, but it’s challenging. It’s not fast and it’s not cheap. Companies that are small and lean—or operate like they’re small and lean—can execute a big change very quickly and without too much expense.

Also, when you work with smaller companies, you can have a relationship with key people that you may not have with a big company. When you know who the right person is at the right level, and you can reach them right away, that leads to fast decision making.

Q: From what you’re seeing as CEO of a CRO during a time of great trans­formation in how trials are monitored, how is the role of the clinical research associate (CRA) changing?

A: The CRA has traditionally been looked at as a low-level employee handling filing and storage, but CRAs can do so much more. Their role is going through a huge transformation. The future might be brighter than people think.

I see companies rediscovering the CRA as a brand ambassador helping with recruit­ing and working closely with the new eTMF technologies. This will be similar to the transformation data management went through with the adaptation of EDC, IWRS and eDiaries. I’m seeing more CRAs playing a vital role in preparing the site for each study. They also have the opportunity, with risk-based monitoring, to be much more focused on technology and processes at the sites, closely managing electronic data manage­ment flow.

I predict they will become much more critical for the future. In five years, the role of the CRA will not even be recognizable when compared to what is today.

This article was reprinted from Volume 20, Issue 09, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »