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News & Events


Upcoming Events in May & June 2017

The BBA team will be attending and presented at several events this spring. EuroPCR – May 16-19, Paris France Arena Outsourcing in Clinical Trials – May 23-24, King of Prussia, PA BBA Podium Presentation: New Study New Challenges: The Power of a…

News & Events


Dr. Joe Massaro to Present at Interim Analysis Symposium

Marlborough, MA – Joe Massaro, PhD, Senior Consultant, BioStatistics at BBA, will present on the topic of Data Monitoring Committees (DMC or DSMB) during his talk titled, “Design and Operate a High-Performing Data Monitoring Committee to Better Assess Trial Outcomes.”  In addition…

White Paper


Boston Biomedical Associates Announces FDA eCopy Services

The FDA’s eCopy requirements for medical device regulatory submission has presented a plethora of new challenges and pitfalls for manufacturers who are trying to navigate the FDA’s regulatory process. If a company is not experienced with the process and requirements, a submission…

Fact Sheet


CDRH Modular PMA Alert – Process Changes

The FDA’s Center for Device and Radiological Health (CDRH) has issued a memo to modular PMA Holders regarding the implementation of PMA process changes that went into effect on June 13, 2016. The memo addresses how incoming Modular PMA submissions will be…

Fact Sheet


Regulatory Information or Regulatory Intelligence? What About ROI?

The following commentary explores the responsibilities of consultants and clients to achieve an effective partnership. A session at the 2015 RAPS’ Regulatory Convergence in Baltimore discussed the differences between regulatory information and regulatory intelligence. Which are you paying for when you hire…

BBA News and Blog

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