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.