Most of the questions sponsors ask us before a study begins aren’t about assay conditions or facility specs. They’re about the relationship: how much to share, when to loop in the CRO, what a strong partnership actually looks like day to day.
This is the first entry in Ask a Study Director, a series where NorthernBio’s study directors answer those questions directly. Rob Davis has spent over 10 years working across early discovery, safety pharmacology and toxicology studies. He shared what sponsors tend to get wrong, what makes collaboration work and what keeps him motivated after a decade in the role.
What sponsors often misunderstand about preclinical studies
One misconception I still see is sponsors treating a preclinical study as a service that runs on its own once the protocol is finalized. The most successful studies are highly collaborative. Interpreting data, especially when something unexpected turns up, usually calls for real time discussion between the study director and the sponsor team.
When sponsors stay engaged and treat the CRO as a partner rather than a vendor, we can offer insight that strengthens the whole program. What matters most is the data a study produces and whether it can confidently guide the next development decision.
What makes sponsor collaboration work
Strong collaboration starts with a clear regulatory strategy, one that shapes the study design around the intended clinical path rather than a standard template. Early investment in bioanalytical methods, PK and ADA work in particular, along with a solid understanding of the molecule helps avoid delays that show up later.
Coordination across study design, operations and reporting matters just as much, since it’s what keeps the data integrating cleanly from one phase to the next. Sponsors who treat the CRO as a partner from the outset tend to de-risk the program and see better outcomes overall.
Advice for first-time IND-enabling sponsors
My biggest recommendation for sponsors preparing for their first IND-enabling study is to bring the CRO team in early. Early scientific discussions let us review available pharmacology, exposure data and formulation considerations before the protocol is finalized, which often uncovers ways to sharpen the study design or flag a challenge before it becomes a problem.
Sponsors who share their broader development strategy help us design studies that hold up against future regulatory milestones too. Early planning is a scientific exercise as much as a logistical one, and treating it that way tends to save time and resources later in development.
Why Rob became a Study Director
I was drawn to the Study Director role because it sits at the intersection of science, leadership and collaboration. The position lets me guide complex studies while working closely with sponsors to solve real development challenges. Each study raises new scientific questions, which keeps the work engaging.
What continues to motivate me is knowing the data these studies generate supports the development of potential new therapies. Contributing to that progress is what makes the role meaningful.
Have a study you’re planning and want to talk through the design with someone who’s seen the unexpected findings before? Consult a NorthernBio scientist or meet more of our study director and leadership team.
Robert T. Davis III, PhD, is a Senior Research Scientist and Senior Study Director at NorthernBio, with over a decade of experience leading nonclinical safety and translational research programs. Having previously held key research roles at Pfizer, Labcorp, and Virscio, he specializes in managing complex, regulatory-ready studies across small molecules, biologics, and advanced modalities like gene therapy. Dr. Davis is known for his scientific rigor and collaborative approach to helping partners advance impactful research programs.