by Melissa Bermudez BioBridges has been engaged by an established specialty pharmaceutical company, located in California, to provide biostatistical expertise in writing statistical protocol for phase 1b design and support clinical programs.
BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide data management expertise to oversee CROs, oversee vendor management, review data, and perform QC for inaccuracies.
BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide medical writing expertise to edit clinical documents, clinical publications, protocols, and perform data QC against source documents.
BioBridges has been engaged by an established biopharmaceutical company, located near Boston, to provide medical and clinical expertise to support a clinical team by ramping up sites, oversee, and direct efforts of site initiation, be responsible for study conduct, and handle medical queries from sites.
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.