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BioBridges | Experience That Works

Avatar by Amy Steinberg · Published May 13, 2020 · Last updated May 13, 2020

BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide medical safety expertise to perform reviews and clarification of trial-related adverse events, serious adverse events, review of case documentation and patient narratives, review of adverse event coding, as well as being accountable for seriousness, causality, expectedness assessments, medical…

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published May 11, 2020 · Last updated May 11, 2020

BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide scientific pharmacovigilance expertise and closely collaborate with the MD, medical monitor, and safety physician, as well as serve as key analytic and provide safety support and data analysis support. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published May 8, 2020 · Last updated May 8, 2020

BioBridges has been engaged by an established, Boston-based, biotechnology company to provide field monitoring expertise, including site monitoring, site selection and initiation, and monitoring visits within GCP, ICH, and regulatory guidelines. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published May 6, 2020 · Last updated May 6, 2020

BioBridges has been engaged by an established biotechnology company, located in the Boston-area, to provide clinical trial management expertise and oversee all operational aspects of a clinical trial, from study planning activities, to study execution and close-out, as well as oversee a phase 3 program, and manage CROs functional teams…

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published May 4, 2020 · Last updated May 4, 2020

BioBridges has been engaged by an emerging biotechnology company, located in North Carolina, to provide clinical trial expertise in preparation for an FDA pre-approval inspection for an NDA submission. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published May 1, 2020 · Last updated May 1, 2020

BioBridges has been engaged by an established, Washington-based, biotechnology company, to provide medical writing expertise in developing several publication projects, such as manuscripts, abstracts and posters, as well as compose regulatory and clinical documentation. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Apr 30, 2020 · Last updated Apr 30, 2020

BioBridges has been engaged by an emerging, Boston-based, biotechnology company, to provide medical writing expertise to develop new protocols and perform document quality control for IND submission.

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Apr 27, 2020 · Last updated Apr 27, 2020

BioBridges has been engaged by an established biotechnology company, located in the Boston area, to provide medical affairs expertise to gain product approval for the commercial market. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Apr 20, 2020 · Last updated Apr 20, 2020

BioBridges has been engaged by an established biotechnology company, located in New York, to provide clinical research expertise for database review, TMF oversight, vendor management, and manage site visits in various locations throughout the United States. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Apr 17, 2020 · Last updated Apr 17, 2020

BioBridges has been engaged by an emerging biotechnology company, based out of Washington, to provide regulatory writing expertise on multiple studies, to manage and mentor junior writers on clinical regulatory documents, protocols, protocol amendments, standard product risk profiles, annual reports, and other various key clinical documents.