Endo International

Carrie Lewis

In light of your experience, what are the trends and challenges you’ve witnessed happening with respect to Clinical Trial Management?

Resources are a challenge in regard to Clinical Trial Management. That is at all levels, CRO, Sponsor, Vendors, and Sites. Some statistics mentioned at conferences state that clinical sites are operating at 60 percent resource capacity. I have firsthand seen struggles in finding the right fit for Clinical Research Associates (CRAs) as well as resource constraints at numerous laboratory vendors.

What are some of the points of discussion that take place in your leadership panel to mitigate these challenges?

One thing I am particularly proud of is our focus on bringing in individuals who are new to the industry or in junior roles. This applies to in-house Functional Service Provider (FSP) roles, as well as to my CRO staff and sites. I have observed that hiring people with limited or no industry experience does not compromise quality. In fact, finding individuals with strong work ethic and a willingness to learn is what matters most; the rest can be taught. In the past, there was often an emphasis on hiring CRAs with 10+ years of experience. However, we recently trained someone with no prior CRA experience, and they excelled, even outperforming our "experienced" CRAs in certain areas.

For years, the industry has discussed the importance of involving more sites in research and including research-naïve sites in studies. However, internally within many companies, there is always a reluctance to find the "right" study to accommodate these research-naïve sites. It's time to move past that mindset. For the growth and longevity of our industry, we need to help educate and empower new people, whether they are CRAs, internal team members, PIs, or coordinators. Let's embrace an open-minded approach and remember that we all started somewhere.

Additionally, one of the key focuses for my team and me in 2023 is prioritizing our clinical trial sites. While I have made significant efforts to be a true partner to our vendors, I have realized that I haven't always extended the same level of partnership to our sites in recent years. Yet, without our clinical sites, we cannot achieve success. These sites operate with limited resources, so it is essential that we reassess how we partner with them and provide the support they deserve. My top challenge this year is to develop the best approach to being a true partner to clinical research sites and enhancing the site pool by working with and training sites that have limited research experience.

As we bring on more inexperienced or junior roles, it is crucial to emphasize empathy. I am collaborating with my team and others to ensure that we show empathy towards our sites and everyone we work with. Are we considering their perspective when making requests, or are we solely focused on our own needs to complete our to-do list or lock a database? Are we recognizing that someone new to the industry may require extra time or additional training? Do we remember our own beginnings and the people who helped us get where we are today? We must take the time to genuinely listen to our sites and understand their needs, rather than solely focusing on our own. Collaboration and partnership are vital to our success.

How do you envision the evolution of Clinical Trial Management in the next few years in terms of potential disruptions and transformations?

I hope that we can break free from the constraints of the past and drive the growth of this industry with new faces and individuals from diverse backgrounds. To continue growing and succeeding, we must be open to teaching new people about our industry and providing them with opportunities to thrive.

I am excited to witness the transformation unfold. Personally, I embrace change and growth. I envision us becoming better leaders, more open-minded, and more empathetic. I believe we will find better ways of doing things. In the next few years, I hope to go to bed at night knowing that I am a true partner to my clinical research sites. Clinical research is a collaborative effort that involves both internal and external stakeholders.

What single piece of advice would you give to a fellow or aspiring professional in your field?

Be open to change! Change can be difficult for many, but it is crucial for our success and growth. How can this critical industry evolve and transform if we, as individuals within it, are resistant to change? Although we may perceive ourselves as open to change and innovative as an industry, there is always room for improvement. Look at the progress made in other industries as inspiration. When I reflect on my own practices, I realize that there are many things I do now that I did the exact same way about 10 years ago. It's 2023, and there are undoubtedly better ways to simplify and enhance this amazing industry. We simply need to be open, take risks, and adapt to keep progressing.