Hello and thank you for visiting my website. I am a British National and came to the US in 1998 with OMRIX biopharmaceuticals, a successful biotech company based in Israel, to manage and direct their clinical development program in the US, leading it to successful licensure.

As I have worked as both Monitor and Project Manager throughout Europe and North America, I am well versed in what is required at the site level. Through my experience as a Senior Management Team member at Omrix, as well as founding and running my own CRO for 10 years, I have a unique and well-rounded set of insights into what is required at the sponsor level in terms of strategy, timelines and budgetary objectives, in order to achieve success in clinical research.

My regulatory strategy is aggressive, transparent, and rooted in the question: “why not ask if we can?” I have been working with the FDA for over 25 years and find that they are quite open and flexible in helping Sponsors achieve their goals while maintaining the safety of the population they serve.

I work in many different capacities, acting as a “one-stop-shop” for all of your clinical and regulatory needs. My services are both self-managing and experience-based, and I offer hourly and fixed-price options that are structured to your budget. I can assimilate into any team and will add value in support of your organizational objectives. And while I am confident in my abilities and experience, I am also able to recognize the areas that are not within my own expertise; in these instances, I also bring a broad network of trusted colleagues with whom I collaborate to the table.

Please contact me to see if my experience can help serve you.

Kind regards,
Sue Bhadare
SBCR Consulting