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BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 23, 2020 · Last updated Nov 23, 2020

BioBridges has been engaged by a Washington-based, biotechnology company, to provide quality validation expertise in 21 CFR Part 11 and support validation activities for an SAS server.

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 19, 2020 · Last updated Nov 19, 2020

BioBridges has been engaged by an emerging, Seattle-based, biotechnology company to provide clinical supply chain expertise to lead and ensure that all supplies are controlled and distributed in accordance with GMP, GCP, and GDP regulations, work with the vendor to ensure that clinical drug supply is available for global clinical…

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 18, 2020 · Last updated Nov 18, 2020

BioBridges has been engaged by an established, California-based, biotechnology company to provide regulatory medical writing expertise to act in a project management capacity, to support the development and workflow of protocols and additional documents, specifically for multiple clinical pharmacology studies, including internal review, comment consolidation, and resolution.

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 16, 2020 · Last updated Nov 16, 2020

BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide clinical data management expertise in a Phase Ib and II program, including performing data review, data checks, and working with CRO’s and Vendors.

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 13, 2020 · Last updated Nov 13, 2020

BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide biostatistical expertise to prepare for filing of an NDA, including generating table shells, reviewing CRO outputs and ADAM specs.

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 11, 2020 · Last updated Nov 11, 2020

BioBridges has been engaged by an established biopharmaceuticals company, located in New York, to provide clinical trial expertise to take responsibility of studies, liaise with vendors and partners, provide CRO oversight, and support internal and external teams ensuring successful conduct in accordance with State and Federal regulations.

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 9, 2020 · Last updated Nov 9, 2020

BioBridges has been engaged by an established biotechnology company, located near Boston, to provide medical directing expertise to impact the final design of protocols for a phase 2 study, lead medical reviews, database lock, and other related medical functions for clinical study.

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 6, 2020 · Last updated Nov 6, 2020

BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide regulatory writing expertise to create, author, and review regulatory documents such as clinical protocols, investigator brochures, DSURs, and manuscripts, for leading programs.

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Nov 4, 2020 · Last updated Nov 4, 2020

BioBridges has been engaged by an established biopharmaceutical company, located in Boston, to provide medical writing expertise for a major submission, overseeing and managing all cross-clinical-document aspects of the clinical content, lead key message development, and ensure top-quality, efficient preparation of content for submission.

BioBridges | Experience That Works

Avatar by Amy Peyser · Published Aug 7, 2020 · Last updated Aug 7, 2020

BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide clinical drug supply expertise to support ongoing clinical trials, ensure continuous supply of clinical trail material for all ongoing studies, and manage clinical packaging and distribution vendors.