February 7, 2019 | Conducting a clinical trial can be both a time consuming and costly affair for pharmaceutical companies. If one is to be successful, they must have their affairs in order, from navigating protocols and regulations to the basic budgeting.

As the Vice President of Clinical Development Operations at Endo, Rosie Filling’s job is to do just that. Since taking the role in February 2018, she’s been responsible for protocol concepts through corporate social responsibility (CSR), and ultimately through any regulatory submission Endo may be compiling.

A biologist by training, Filling has more than 20 years of experience in the clinical trial industry, exposing her to all functional groups responsible for the execution of a clinical trial.

On behalf of Clinical Research News, Lee Yuan spoke with Filling about the challenges that come with outsourcing clinical trials, what innovations excite her, and what she’s looking forward to as the industry progresses.

Editor’s note: Lee Yuan, a Conference Producer at Cambridge Healthtech Institute, is planning a track dedicated to Managing Outsourced Clinical Trials at the upcoming Summit for Clinical Ops Executives, SCOPE, in Orlando, February 18-21. Filling will be giving a co-presentation at the program. Their conversation has been edited for length and clarity.

Clinical Research News: What do you feel are the biggest challenges in outsourcing clinical trials today, and why?

Rosie Filling: Currently I think the biggest challenge a lot of management is continuing to hear is knowing how to save costs while maintaining quality. It's definitely that model of “do more with less.” I think as an industry we are constantly being challenged to evaluate cost saving measures, and that leads us to many different questions. Do we change our trial designs? Do we execute our clinical trials differently? Going through the evaluation process is best for the program as well as for your company. Trials are continuing to become more and more expensive. Some of that is certainly related to the requirements that are being enforced by certain regulatory bodies. But as our trials are becoming more and more complex, and when building budgets, it's very easy for many of us to use previous estimates that we may have from our past experience, etc. Now, we really have to take a step back and look at the many different factors that are driving the additional costs and how those can be offset.

What innovations in the trial space have you most excited, and why?

I think there's a lot going on out there. One thing in particular, I think, that's exciting and has been certainly creating some noise over the past several years, is patient engagement. I still think we have come a long way over the past five to seven years in terms of both patient engagement and eCOA [Electronic Clinical Outcome Assessment], but I still think we have a lot of growth potential in that area. I'm excited to see where that goes.

Another one is the oversight of our CROs [Contract Research Organizations] and, in particular, our CRAs [Clinical Research Associates]. Having efficient processes to ensure that we have appropriate oversight, that we're giving appropriate oversight, and not causing more complexity or harm to the clinical trials is crucial.

In general, what are you excited about in the industry?

Right now I think there needs to be a lot of focus on true partnerships. I think if you ask any CRO or any vendor out there, and even some pharma companies, are you really executing in a true partnership model? I think you'd be surprised with the responses that you would get. I think it's important, and I like to speak about investing the time and effort in building relationships. Don't give up too soon. Stick it out with your vendors; try to make it work. I have been fortunate to set up different models at many different pharmaceutical companies, and while my function is to ensure that we execute our portfolio with the greatest quality at the best cost, I have also instilled a culture in these places to ensure that our suppliers are set up to succeed and deliver for our teams as well.