by Chelsea Olson 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.
BioBridges has been engaged by an established biopharmaceutical company, located in Boston, to provide medical writing expertise for a major submission, overseeing and managing all cross-clinical-document aspects of the clinical content, lead key message development, and ensure top-quality, efficient preparation of content for submission.
BioBridges has been engaged by an established, Boston-based, biopharmaceutical company to provide clinical drug supply expertise to support ongoing clinical trials, ensure continuous supply of clinical trail material for all ongoing studies, and manage clinical packaging and distribution vendors.
BioBridges has been engaged by an emerging biotechnology company in Connecticut, to provide quality assurance expertise in performing source verification of data in narratives, as well as editing and formatting narratives to align with corporate styles.
BioBridges has been engaged by an established biopharmaceutical company in Boston, to provide publication writing expertise in developing manuscripts for genetic research.
BioBridges has been engaged by an established biopharmaceutical company in Pennsylvania, to provide pharmacovigilance expertise to oversee decisions and processes pertaining to medical affairs and safety.
BioBridges has been engaged by an established, Boston-based, biotechnology company to provide quality assurance expertise to support overall implementation of a QMS system, perform hands-on medical device quality management, and support the authoring and approval of validation reports.