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BioBridges | Experience That Works

by Amy Steinberg · Published Sep 13, 2019 · Last updated Sep 13, 2019

BioBridges has been engaged by an emerging, San Francisco-based biotherapeutics company to coordinate and oversee all CMC and analytical development efforts, ensure the program meets proper non-GLP and GLP requirements, and confirm that method validations are properly developed.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 12, 2019 · Last updated Sep 12, 2019

BioBridges has been engaged by an established, oncology-focused biopharmaceutical company to provide phase III data management expertise, vendor and CRO management, and general cross-functional support to ensure appropriate work is accomplished according to schedule.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 9, 2019 · Last updated Sep 9, 2019

BioBridges has been engaged by an established, Massachusetts-based pharmaceutical company to provide strategic and hands-on safety and pharmacovigilance guidance and support for a large phase III clinical study.

BioBridges | Experience That Works

by Amy Steinberg · Published Sep 6, 2019 · Last updated Sep 6, 2019

BioBridges has been engaged by an established biotechnology company to perform an in-depth GCP audit of their central testing laboratory.

BioBridges | Experience That Works

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

BioBridges has been engaged by a San Francisco based biotechnology company to provide strategic and hands-on quality support and expertise as they begin analytical validation of their lead clinical product and prepare their laboratory site for CLIA certification.

BioBridges | Experience That Works

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

BioBridges has been engaged by a clinical-stage biopharmaceutical company to provide pharmacovigilance expertise and operate as an overall internal advisor for the safety and pharmacovigilance group.

BioBridges | Experience That Works

by Amy Steinberg · Published Aug 28, 2019 · Last updated Aug 29, 2019

BioBridges has been engaged by an emerging, Boston-area, biotherapeutics company to support the authoring, editing, formatting, and coordination of an upcoming IND.

BioBridges | Experience That Works

by Amy Steinberg · Published Aug 23, 2019 · Last updated Aug 23, 2019

BioBridges has been engaged by an emerging biotherapeutic company to provide overall strategic quality assurance expertise and functional management support.

BioBridges | Experience That Works

by Amy Steinberg · Published Aug 21, 2019 · Last updated Aug 21, 2019

BioBridges has been engaged by an established bio-pharmaceutical company to provide hands-on medical writing support by creating IB updates, regulatory responses, protocol amendments, CSRs, updates to clinical overviews, and core dossiers.

BioBridges | Experience That Works

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

BioBridges has been engaged by an established, San Francisco-based pharmaceutical company to provide bio-statistical expertise to two new early clinical programs by supporting fractional factorial design, reviewing study designs and creating statistical protocols.