In May 2019 Clinical Leader Live was proud to feature Laurie Halloran, president and CEO of Halloran Consulting Group. Ms. Halloran presented on the topic of In-House Vs Outsource: Decision-Making Considerations. During the presentation, she covered balancing growth with your outsourcing needs, the organization maturity model, the transformation of the clinical operating model, performing an accurate self-assessment, and determining what outsourcing model is best for you. In this video, Halloran discusses the trends in CRO outsourcing.
Ed Miseta: Are you seeing any clear trends? The cost of outsourcing seems to keep going higher and higher. I'll talk to one company that is bringing everything back in house because it wants those capabilities internal. The next week I’ll talk to another company that is outsourcing everything. Are there any clear trends that you see happening right now?
Laurie Halloran: I do. If you are very small with one program and a handful of clinical operations people, you really need to outsource. But we have multiple clients right now who have one or two or three products that are late stage or on the market and they're not really getting the level of value from their rent, especially from their CROs, and they're going to make a decision to build for internal capabilities.
The first thing they really need to do is look at the development plan for the programs that they're thinking about bringing in. Then they need to look at what the appetite is for risk in executive management and they need to do a gap analysis on what the organization doesn't have to grow, so we are seeing that. The bigger you are, the harder the effort needs to be, because the more you have to change. If you have 20 department heads, it is a lot to change.
Ed Miseta: It seems like you also have to, at some point, categorize your activities and decide what you can outsource and what it is that you're going to keep it in house. Is it difficult for a lot of the smaller companies that do that?
Laurie Halloran: No, not really. What a lot of companies elect to try to start building, at least the ones that we're seeing, is two things. One is clinical project management. They're taking the project management back because, in a lot of situations, you're redoing a lot of the work of managing the project.
There's not a clear line between vendor oversight and project management in a lot of situations so, a lot of times, they'll just outsource the CRA and the monitoring. Then the other big thing, and you may elect to do both at the same time, is data management. Because data management is so much EDC based now, if there's an ability to hire in a data management team or a couple of folks, you can switch that over and then you have control of your data.
This tends to be a very big area of challenge when you're outsourcing everything because, if you're not big enough to really command the instant performance and your senior management team really wants to see the data or see results, you're hamstrung by being able to get that data or cut to the data or updates or whatever.