What Issues Should Be Part Of Your Outsourcing Decision?

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 determining what outsourcing model is best for you. In this video, Halloran discusses what issues should be part of your outsourcing decision.

Click here to see the complete interview.


Question: What issues should be part of your outsourcing decision-making process?

Laurie Halloran: This is a topic that I'm starting to see come up more and more with clients and colleagues. To put it in context, more and more companies are starting to think about what they want to keep as their internal competencies and capabilities, because the world of outsourcing gets more and more challenging for small companies who don't have $100 million to spend.

I'm starting to think about, and starting to explore, another whole area around vendor oversight. I'm actually at a Vendor Oversight Risk Management Conference right now, which is why this is really top of mind, but we believe there are a lot of reasons for the clinical trial execution and the challenges with this.

In a lot of companies, and this is something for you to reflect on in your own company, there's an excessive amount of decision-making by committee. What this really means is that there's not one individual who's personally accountable for making decisions and there's a lack of risk taking. That's not in the ICH E6 (R2) risk mode, but in being the advocate for the project and making some decisions.

The other thing that happens, and this is more in larger companies, not so much in small companies just because they don't really have the people, is there are a lot of functional silos where there are individual groups that don't talk to each other and this tends to be in data management, bio sets, clin ops, clinical development, et cetera.

In bigger companies, there's a lot of redundancy and bloated organizational structures because there's been lots of mergers and acquisitions. If you're in a small company, these are the things that you want to be mindful of as you grow and as you potentially look to bring in other products or other companies.

I also did cover the excessive risk aversion. We see this a lot with clinical development folks and it really is somewhat in the mindset of people who grow up in clinical research but, at some point in time, you have to be willing to jump in there and take some risks.