Clinical Study Design

Innovation in medicine requires strategic planning, from concept to final product and market adoption.  What is the best way to demonstrate safety and effectiveness?  How do you balance the challenge of developing a product, assessing its safety and effectiveness in patients and meeting global regulatory requirements?  Will this be accomplished in a single clinical study or several?  The answers to these questions take experience and planning.

BBA’s dedicated Consulting Services team has developed an extensive range of clinical trial design strategies for over 25 years.  From pre-clinical to post-approval, for both large and small companies, our teams of senior advisors have expertise and understanding of the complexities and nuances of clinical development for a regulated industry.  Our consultants combine clinical understanding with regulatory requirements and expectations to develop the most effective clinical trial for clearance or approval and market adoption.

BBA’s study design team includes experienced clinical researchers with a breadth of knowledge in many therapeutic areas which enables you to capitalize on our collective experience and meet the clinical goals of the project.  Partnering with you, we help determine the best course of action for your trial, with scientifically sound justifications and appropriate trial designs, ranging from simple single endpoint frequentist study designs to sophisticated Bayesian adaptive clinical trial design.

BBA has extensive experience with a variety of medical device clinical trials and programs, including PMA and 510(k) studies and studies of therapeutic, diagnostic and surgical devices. Recent successes include enhancing studies through adaptive and Bayesian design resulting in decreased trial duration and early product approval.

We deliver study designs balanced to meet your business needs and expectations with the current scientific understanding and all regulatory requirements considered.

Allow us to help propel your product forward. 

The Boston Biomedical Associates team was instrumental in their support of AtriCure in executing our ABLATE trial, interacting with the FDA and preparing for the panel meeting. We are impressed with their extensive clinical and regulatory expertise as well as their professionalism and appreciate their support in working with us to achieve a positive panel vote.
— David J. Drachman, Former President and Chief Executive Officer of AtriCure, Inc.

To connect with an expert and develop a study design that ensures your clinical goals are met

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