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BioBridges | Experience That Works

by Amy Steinberg · Published Oct 7, 2019 · Last updated Oct 7, 2019

BioBridges has been engaged by an emerging, medical device company to provide a clinical development team that will provide hands-on expertise and strategic support in the following areas; program direction and management, regulatory support, statistical support, quality assurance, medical writing, site monitoring, and medical monitoring.

BioBridges | Experience That Works

by Amy Steinberg · Published Oct 4, 2019 · Last updated Oct 4, 2019

BioBridges has been engaged by an established, Philadelphia-based pharmaceutical company to prepare a manuscript for publication in a toxicology journal.

BioBridges | Experience That Works

by Amy Steinberg · Published Oct 2, 2019 · Last updated Oct 2, 2019

BioBridges has been engaged by an emerging biotherapeutic company to perform a site-audit for a newly selected CRO and provide overall guidance in developing internal audit SOPs and general QA systems and templates.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 30, 2019 · Last updated Sep 30, 2019

BioBridges has been engaged by an emerging biotherapeutic company to provide overall study-start-up expertise; including vendor selection, clinical site selection, site enrollment, and feasibility studies.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 27, 2019 · Last updated Sep 27, 2019

BioBridges has been engaged by an emerging pharmaceutical company to oversee and contribute to the finalization of several regulatory documents, including protocols, briefing packages, a pediatric investigational plan, and an orphan drug application.  

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 25, 2019 · Last updated Sep 25, 2019

BioBridges has been engaged by a clinical-stage pharmaceutical company to work directly with health care practitioners to support the planning, development, writing, and submittal of numerous case studies and manuscripts that depict their real-world experience prescribing the company’s drug to patients.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 23, 2019 · Last updated Sep 24, 2019

BioBridges has been engaged by an emerging, San Diego-based biotherapeutic company to provide strategic and hands-on biostatistics support and guidance for three early clinical programs.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 20, 2019 · Last updated Sep 20, 2019

BioBridges has been engaged by an emerging pharmaceutical company to lead overall data management activities for a phase II clinical program; including oversight of outsourced clinical studies, EDC systems and processes, vendor management, coordination of data review, and approvals of clinical data deliverables.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 19, 2019 · Last updated Sep 19, 2019

BioBridges has been engaged by a Boston-based pharmaceutical company to lead overall CRO interaction, site enrollment, and project management.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 16, 2019 · Last updated Sep 16, 2019

BioBridges has been engaged by a clinical-stage biopharmaceutical company to guide site identification and selection for a complex oncology study.