by Amy Peyser BioBridges has been engaged by an emerging biopharmaceutical company, located near the San Francisco Bay area, to provide clinical program management expertise to support the implementation of clinical project plans and provide oversight of clinical operations and development activities.
BioBridges has been engaged by an emerging biopharmaceutical company, located near Boston, to provide clinical regulatory writing expertise to directly author content to be utilized in various regulatory documents and QC existing content that needs development.
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 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 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 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 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 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 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 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.