Partnerships for the Entire Lifecycle

BBA prides itself on building and sustaining long-term relationships with our clients and strategic partners. We believe that our clients and partners are best able to provide objective feedback to the quality of our services. We actively seek out feedback on the quality of our work in order to improve our processes when necessary and provide you with the best service possible.

Boston Biomedical Associates shows a passion for supporting companies as they develop their technologies to make an impact on healthcare and the marketplace. BBA has a deep pool of experience for developing effective and efficient regulatory strategy, clinical strategy and protocol writing, as well as networking with KOLs. BBA understands the needs of a fast paced young and growing start up, and provides their services in a courteous, supportive and patient manner.
— Dustin Arless, Clinical Development at SoundBite Medical Solutions Inc.
Our recent PMA submission and approval took 8 months from filing to approval. We worked with BBA as a statistical consultant throughout the development and execution of the HeartLight pivotal clinical study. BBA delivered high-quality statistical services throughout the study and PMA process. We are very appreciative of their valuable statistical insights.
— Burke T. Barrett, Vice President of Regulatory & Clinical Affairs at CardioFocus

We are delighted to have worked with a company like BBA that offered us the full spectrum of clinical and data management services, with an integrated approach to study design, data management, statistical analysis and report generation. BBA’s team of industry leading experts was committed to servicing our needs and delivered high-quality results.
— Barbara S. Lindsay, Vice President at Benvenue Medical, Inc.
While collaborating with BBA to prepare our mutual client for successful FDA PMA Panel meeting, I was able to see first hand the quality of BBA. I have thoroughly enjoyed working with the BBA team. They provided an unparalleled level of dedication and service to their clients.
— Jim Dibiasi, 3D Communications, LLC

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.
Boston Biomedical Associates, like Neocure builds long-term partnerships with their clients to accelerate patient access to innovative medical products. BBA recognizes the need to implement a reimbursement strategy early on in the planning process to optimize market share at product launch with needed economic data.
— Randel Richner, President and Founder of Neocure Group, LLC.

Boston Biomedical Associates understands the benefits of the Bayesian adaptive approach to clinical trial design. While partnering with BBA to provide adaptive clinical trial designs, I have seen how BBA provides thoughtful and aggressive strategic advice to its clients. BBA is dedicated to helping its clients using innovative and accurate statistical designs and analysis plans in line with current FDA guidance and FDA’s critical path initiative.
— Jason Connor, Ph.D. 
Statistical Scientist – 
Berry Consultants

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