by Amy Steinberg BioBridges has been engaged by an emerging biotechnology company, based out of Washington, to provide clinical regulatory writing expertise for early stage programs by developing protocols, protocol amendments, standard product risk profiles, annual reports, IBs, ICFs, DSURs, CSRs, and other key clinical documents.
BioBridges has been engaged by an established, Connecticut-based, biopharmaceutical company to provide medical writing expertise and lead the development of a CSR for a QTc study, produce clinical documents, protocols, protocol amendments, submission documents, and briefing books.
BioBridges has been engaged by an established, Boston-based, biotechnology company to provide clinical data management expertise for all aspects of their global clinical study data management processes from start-up to database lock to regulatory submission, as well as ensure clean and valid clinical study data for delivery to biostatistics.
BioBridges has been engaged by an established, California-based, biotechnology company, to provide data management expertise for a multi-phase program in the overseeing and managing of data function, while transitioning from a CRO to their personal facility.
BioBridges has been engaged by an established, Cambridge-based, global biotechnology company to provide medical writing expertise to author, develop and support multiple CSRs.
BioBridges has been engaged by an emerging, virtual biotechnology company, based out of Rhode Island, to provide clinical project management expertise for European products with current study approvals, and United States products pending approval.
BioBridges has been engaged by an emerging virtual biotechnology company, based out of Rhode Island, to provide clinical project management expertise on products with current study approvals in Europe, and pending approvals in the United States.
BioBridges has been engaged by an established, Boston-based, biotechnology company to provide clinical data management expertise and CRO oversight, including; data review, data cleaning, and overseeing builds and database lock, for multiple ongoing trials.
BioBridges has been engaged by an established biopharmaceutical company, based out of the Boston area, to provide trial master file management and administration, while supporting additional activities across multiple clinical development programs.
BioBridges has been engaged by an established, California-based, biotechnology company to provide clinical trial management expertise by supporting the planning and execution of phase studies, building effective vendor relationships, investigating internal and external partner sites, and proactively identifying, managing and communicating risks to key stakeholders.