About Sue Bhadare

Bringing 25+ years of hands-on clinical development and regulatory expertise to bio/pharma & MedDev companies worldwide

For more than two decades, I've partnered with start-ups, small biotech firms, and mid-sized therapeutics and medical device companies, with 90% being international clients navigating the U.S. regulatory landscape. My expertise bridges clinical development, regulatory strategy, and operational excellence.

Having been both a CRO owner and a Sponsor consultant gives me unparalleled insight into what makes partnerships successful—and what doesn't. I understand both sides of the table, which means I can help you avoid common pitfalls and maximize the value of your CRO relationships.

My Journey

1992

Entered Clinical Research

Joined a plasma therapeutics company as a CRA, advancing to Clinical Director for EU and US operations. Contributed to senior management efforts in securing FDA and EU approvals.

2002

Founded CRO

Established and managed a Contract Research Organization for ten years, specializing in plasma therapeutics and small biotech clients. Built the company around customer-focused service, quality operations, and a deep understanding of rare disease indications.

2013

SBCR Consulting, LLC

Launched an independent consulting practice focused on clinical operations support, CRO management, and quality processes. Apply operational insights from a decade of CRO leadership to help biotech and medical device companies optimize their programs, with expertise in FDA representation, Pre-IND/IDE strategy, and operational excellence.

"When Sponsors come prepared with relevant questions, the FDA is remarkably supportive. My role is to help you engage early, ask the right questions, and build constructive relationships with your review team."

— Sue Bhadare

How I Work

Hands-on Approach

I don't just advise—I roll up my sleeves and work alongside your team, creating documents, solving problems, and keeping studies moving forward. I require minimal management and just “run with it”.

Independent Perspective

As an independent consultant, I provide unbiased recommendations focused solely on your program's success—no vendor relationships or internal politics to influence my advice.

Strategic Thinking

Every decision is informed by competitive intelligence, feasibility analysis, a deep understanding of what FDA expects, GCP requirements and what actually works in practice.

Practical Solutions

I've seen what works and what doesn't. My motto, “Less is More”. My solutions are grounded in real-world experience, designed to be operationally feasible and scientifically sound.

Beyond the Work

I'm based in downtown Nashville, Tennessee, where I enjoy the city's dynamic atmosphere and vibrant culture. Music City's energy and creativity inspire my approach to problem-solving in clinical development.

I'm also a proud parent of three accomplished adults who have launched their own careers. Watching them navigate their professional journeys reminds me of the importance of mentorship and supporting the next generation.

QUICK FACTS

Arrow pointing to the right
A teal-colored arrow pointing to the right.
A teal arrow pointing to the right.
A teal-colored arrow pointing to the right.
Right arrow icon on a transparent background

Based in Nashville, TN

30+ CBER/CDER/CDRH meetings

Rare disease specialist

Former CRO founder

Serving international clients

Let’s Work Together

Ready to discuss your clinical development program?

Get in Touch