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BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Apr 15, 2020 · Last updated Apr 15, 2020

BioBridges has been engaged by an emerging biotechnology company, based out of Washington, to provide clinical regulatory writing expertise for early stage programs by developing protocols, protocol amendments, standard product risk profiles, annual reports, IBs, ICFs, DSURs, CSRs, and other key clinical documents. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Apr 13, 2020 · Last updated Apr 15, 2020

BioBridges has been engaged by an established, Connecticut-based, biopharmaceutical company to provide medical writing expertise and lead the development of a CSR for a QTc study, produce clinical documents, protocols, protocol amendments, submission documents, and briefing books. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Apr 10, 2020 · Last updated Apr 10, 2020

BioBridges has been engaged by an established, Boston-based, biotechnology company to provide clinical data management expertise for all aspects of their global clinical study data management processes from start-up to database lock to regulatory submission, as well as ensure clean and valid clinical study data for delivery to biostatistics. 

BioBridges | Experience That Works

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

BioBridges has been engaged by an established, California-based, biotechnology company, to provide data management expertise for a multi-phase program in the overseeing and managing of data function, while transitioning from a CRO to their personal facility.  

BioBridges | Experience That Works

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

BioBridges has been engaged by an established, Cambridge-based, global biotechnology company to provide medical writing expertise to author, develop and support multiple CSRs. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Apr 3, 2020 · Last updated Apr 3, 2020

BioBridges has been engaged by an emerging, virtual biotechnology company, based out of Rhode Island, to provide clinical project management expertise for European products with current study approvals, and United States products pending approval.

BioBridges | Experience That Works

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

BioBridges has been engaged by an emerging virtual biotechnology company, based out of Rhode Island, to provide clinical project management expertise on products with current study approvals in Europe, and pending approvals in the United States.

BioBridges | Experience That Works

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

BioBridges has been engaged by an established, Boston-based, biotechnology company to provide clinical data management expertise and CRO oversight, including; data review, data cleaning, and overseeing builds and database lock, for multiple ongoing trials. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Mar 25, 2020 · Last updated Mar 25, 2020

BioBridges has been engaged by an established biopharmaceutical company, based out of the Boston area, to provide trial master file management and administration, while supporting additional activities across multiple clinical development programs. 

BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Mar 23, 2020 · Last updated Mar 23, 2020

BioBridges has been engaged by an established, California-based, biotechnology company to provide clinical trial management expertise by supporting the planning and execution of phase studies, building effective vendor relationships, investigating internal and external partner sites, and proactively identifying, managing and communicating risks to key stakeholders.