After working in management positions for both a large pharmaceutical/medical device company and then a small start up, she decided to branch out on her own and founded B2Research Consulting in 2011. She holds degrees in both Pharmacy and Education. Amy understood there was a need for experienced clinical research professionals in the market place and felt she could fill the void that many organizations have with their teams. Whether it is a large company or a small start-up firm, Amy brings extensive experience in medical device, proprietary pharmaceuticals and combination products to our clients.
Amy specializes in clinical study operations where she can give our clients the support in all aspects of clinical trial management, clinical logistics and study oversight (US and EU). This includes generating timelines and budgets, managing CEC/DSMBs, site selection, CRO management.
Amy's goal for our clients is to have them transition seemlessly from study start-up into enrollment then study close-out and finishing with a well written clinical study report.
Chris joined his partner and founder of B2 Research Consulting, Amy Barry, to bring another aspect of Product Development to their customers. Chris has >20 yrs experience managing R&D, Quality and Manufacturing organizations in support of new product introductions.
In his last role as Vice President of R&D/Operations at Lutonix, Inc., Chris led all efforts associated with a novel, combination product that was a "first of its kind" device here in the US. He participated in all FDA interactions from formal meetings, to site inspections to the FDA Advisory Panel convened for the Lutonix Drug Coated balloon in June 2014.
Chris is able to bring to our clients an in-depth knowledge of the drug/device development processes consisting of formulation development, device design, manufacturing, regulatory and quality assurance. While working at both large companies and start-up firms, Chris established himself as an exceptionally resourceful decision-maker that combines strong leadership and organizational skills with the ability to direct high-level business affairs.
Chris received his Chemistry degree from the Univerity of Notre Dame.