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.

BBA is unparalleled in both the quality of their work and responsiveness to timelines. Their commitment to data integrity and statistical knowledge is exemplary and truly sets the gold standard. For me, the commitment and responsiveness of the statistical team was simply amazing. The team was always available no matter when or what time I had questions or requests. The team’s knowledge of clinical trials, and excellence in strategic thinking is a joy to partner with.
— Jennifer Sahatjian, Director of Clinical Operations at Cheetah Medical
EmpiraMed has been delighted to partner with Boston Biomedical Associates for a number of post-launch observational studies. The flexibility in our partnership is unparalleled and allows us to make changes to studies, respond to RFPs and engage our biotech customers in new projects in very short timelines. The ability of their staff to work with us to design and craft studies for our customers is invaluable.
— Neil Minkoff, MD, Chief Medical Office at EmpiraMed
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 is a highly intellectual and analytical CRO with expertise ranging from early stage product and clinical development through US and OUS regulatory approvals, They continually surpass industry standards and are committed and dedicated in conducting high-quality, FDA-regulated clinical studies. In my experience they operated in a collaborative and results oriented fashion. They are consistently ahead of the curve and offer exceptional CRO services.
— Ken Malomo, Clinical Operations Consultant at Metavention, Inc.
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
As an early stage, MedTech startup, you are only as strong as your next round of funding. And no three letters give an investor more pause then “FDA”. Fortunately, months of collaboration with BBA helped produce a very successful PreSubmission meeting, the results of which have become the cornerstone our future fundraising efforts. Throughout the process, we have been pleased with not only BBA’s regulatory strengths, but also their understanding the powerful stresses startups face. Bottomline: BBA has become a critical strategic partner in helping prepare the VENTRIFLO® True Pulse Pump for successful market clearance so that we can fulfill our mission of providing improved healthcare options to some of the sickest cardiac patients while helping achieve lower overall total costs.

-Doug Vincent, President and CEO – Design Mentor


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