How Smaller CROs Can Deliver Big Value

By: Jessica Schneider

Working in clinical operations for over a decade, I have noticed that there are several factors that lead to study success. While protocol design and enrollment strategy are both important, I have found that the difference between successful and struggling studies often comes down to the right people, strong operational planning, and the ability to adapt quickly. Sponsors routinely face challenges that require fast decision making, regardless of a trial’s size or complexity. In some organizations, complex team hierarchies are added to the equation and decision making becomes slow and inefficient.

This matters because delays in addressing operational challenges can jeopardize timelines, increase costs, and ultimately impact study success.

I have worked on both small and large studies, with small and large sponsors. The most successful studies have consistently had the flexibility to adapt to the changes needed to address a concern and the people around to make those final decisions.

One of the most exciting things about working in my current role is seeing firsthand how much of a difference the ability to adapt quickly and collaborate effectively can make. I work with colleagues who know our processes, understand their role in the bigger picture, and genuinely care about study outcomes. There is a strong sense of ownership across the team because everyone understands how their work contributes to the success of the study.

Also, by giving our sponsors direct access to leadership, I have witnessed the added value that results in strategic collaboration, faster escalation pathways, and a greater transparency and trust.

Every study is different, and a one-size-fits-all approach rarely works. When we can customize project plans, adapt reporting requirements, and learn our sponsors’ preferences, we can create meaningful operational advantages. My goal, working in operations, is to function as an extension of the sponsor’s team, not something separate. Teams are better positioned to maintain study momentum when they are empowered to respond to enrollment challenges, reallocate resources, and of course adapt to changes resulting from a protocol amendment, which we all know is inevitable in a study’s lifecycle.

I thrive in an environment built on transparency, accountability and connectivity with my team, because I have seen its success in action firsthand. We hold each other accountable, not only because we have to, but we all know our parts to play are what produce our success. A smaller CRO environment has given me the opportunity to see these advantages play out in real time.

With all that being said, I believe the studies that seem to succeed are those that have the right people and the ability to adapt. I have been fortunate to see those qualities every day and look forward to what lies ahead.

About the Author

Jessica Schneider is the Associate Director of Clinical Operations and Senior Project Manager at CTRG, where she leads clinical trial operations and supports cross-functional teams through operational oversight across the organization.   She uses her background in clinical site operations and coordination, site management, project management, and clinical monitoring to help sponsors navigate complex clinical trial operations and drive successful outcomes in retina research.