Transformation of the Clinical Operating Model

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, performing an accurate self-assessment, the trends in CRO outsourcing, and determining what outsourcing model is best for you. In this video, Halloran discusses the transformation of the clinical operating model.

Click here to see the complete interview.


Question: What Does the transformation of the clinical operating model look like? And how do we get from here to there?

Laurie Halloran: If you're thinking about how to change what you're doing, and this is very oriented towards vendors, vendor selection, vendor use and thinking about building your own inter internal capabilities, what you really need to think about is if you're going from here to there, whatever new is, you really have to break it down into four major areas.

First of all, what's the reason? I'm going to frame this to the small company, because this is the audience that's on this call. If your strategy is to build your internal capabilities so that you're not so reliant on vendors, then think about why that is.

We run into a lot of companies where the head of clinical, and sometimes the chief medical officer, just does it the way they've done it at their last company. That's not necessarily what you should be considering.

Really the thing to think about is what is our overall business plan? Is our management team going to bring in a whole lot of new products? Do we have a really rich pipeline? Do we want to build internal capabilities? Do we want to own our data and have a certain level of folks in the organization like clinical project managers so that we have a little bit more control over our data?

These are all the kinds of things that you really need to flush out ahead of time and sometimes that means getting out of your comfort zone or talking with someone who's not in the organization on a daily basis. The structure of the organization and the level and type of people should really be driven by that strategy, because there's really no point in having a whole bunch of junior people if you don't have any senior people and vice versa.

You also really have to identify what you're going to bring in, both business process and level of complexity. You wouldn't have data management SOPs if you don't have data management. That extends to the business processes and the methodology and it also extends to both data and technology.

We are living on the edge of the best time, probably in anyone's history, in clinical development, because there is so much data and technology out there that really should be making things more efficient. 

We're not quite there yet so everything is a little bit of an experiment and you have to really understand that and understand where you want to tackle with your biggest set of dollars and your biggest areas of competencies before you really go and just start having lots of different apps for lots of different potential uses.

We see a lot of people who take a very unsystematic approach and they don't get the value out of the money that they spend on technology. All of these components are really around optimizing your organization.