by Amy Steinberg 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 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 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 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 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 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 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 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 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 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.