Operational Excellence

In clinical operations, operational excellence, in my opinion would be delivering on time, with quality, first time, with very little oversight required from the client's perspective.

What we do is we provide a mechanism in which we're continuously and we're consistently improving on the way in which we deliver for our customers.

We have specialized teams that we put together some governance and some framework in which we are always looking at where are those critical pain points in the industry? What are the things that we need to make sure that we're staying ahead of the market?

I think what our customers are looking for is they're really looking for our knowledge in regards to how to run and drive their projects and their programs.

And what we do is we look at the end in order to plan for the beginning.

Whether it's just collecting the data and making sure that the site gets access to the systems, whatever it may be, on the clinical side, our job is really just to be fully aware of what technologies are out there, what is available to the patients and the study coordinators, and we need to be able to accommodate that so that it is as seamless as possible.

I think another pain point for our sponsors is really in regards to cycle time. It's that start up process at the very beginning.

We need to make sure that we get out of the gates fast. So they're looking at us in regards to making sure we're leveraging those best sites.

Looking at making sure that we have the right patient populations and we're leveraging the right data in order to monitor their trial at the highest quality.

Recently, I've certainly seen pressures out in the industry, shortages of staff, competing priorities, heavy workloads for the study coordinators.

So I often tell my series your job is to make it as easy for them as possible, right?

We want them to participate in the study. We need it to be easy for them to follow the protocol, make sure our inclusion/exclusions are complied with, and that they can get their data entered in a timely manner.

The environment in drug development has changed quite a bit. It's continuing to be more and more complex.

I think we will constantly be living in this change environment where we have to continue to advance to adapt, to look at ways in which we can be innovative and also look at ways in which we can be agile and provide some innovative solutions for our customer and to stay relevant within the market.