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, the trends in CRO outsourcing, and performing an accurate self-assessment. In this video, Halloran discusses how to determine what is the best outsourcing model for you.
Ed Miseta: For somebody considering the best outsourcing model for them, it seems like you would almost have to come up with a list of positives and negatives for both models and decide which one lies more in your favor. Do you ever have companies do that or do you personally explain to them what you think the positives and negatives of both are and how that relates to their company size and what they're doing?
Laurie Halloran: Yeah, we do, and this ties back to what we discussed a few minutes ago. We look at their business model, we look at their appetite and, a lot of times, the executive management dictates what they would rather have.
I would say one big thing in thinking about this is to look at your senior management team. Look at your chief medical officer, if you have one, and see whether or not they're frustrated by being hamstrung with their vendors. If the plan is to stay as a development entity that's going to ultimately try to commercialize, there's going to be a very big appetite for decreasing some of those outsourcing costs.
Ed Miseta: There are certainly a lot of technologies out there that can help with or accelerate your data collection and analysis. I guess that would be another option as opposed to maybe having someone else do it for you. At what point should a small company consider implementing technologies to help out with that?
Laurie Halloran: You can do that before you ever even start a clinical trial. There are some good vendors out there that will help you with oversight and with managing the CRO. The challenge is going to be that a lot of CROs want to use their own systems and they give you access in the process.
They tell you that you have instant access, but then it's not really that easy to get the access. You can take that over and basically have your own cloud-based CTMS that they have to enter the data into on the trial management metrics. But expect that you're probably going to have to pay for that if the CRO isn't already using it.