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 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 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 has been engaged by an established biotechnology company to perform an in-depth GCP audit of their central testing laboratory.
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 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 has been engaged by an emerging, Boston-area, biotherapeutics company to support the authoring, editing, formatting, and coordination of an upcoming IND.
BioBridges has been engaged by an emerging biotherapeutic company to provide overall strategic quality assurance expertise and functional management support.
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 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.