by Amy Steinberg 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 in Washington, to provide clinical writing expertise in leading the medical writing team and oversee development of content using available resource materials, as well as advise internal professionals.
BioBridges has been engaged by an established, California-based, biotechnology company to provide regulatory publishing expertise to support the regulatory affairs team in planning, publishing, submitting, and archiving regulatory documents.
BioBridges has been engaged by an established, Pennsylvania-based, biopharmaceutical company to provide medical expertise in the therapeutic areas of hematology and oncology, as well as provide strategic and tactical clinical perspective and guidance to client R&D initiatives and programs.
BioBridges has been engaged by an established biopharmaceutical company in California, to provide regulatory management expertise to track the planning and progress of regulatory submissions deliverables, including managing IND submission lifecycles, and conducting qualitative documentation analysis to ensure consistency among documents, and readiness for health authorities.
BioBridges has been engaged by an established, California-based, biotechnology company to provide trial master file expertise to review, assess, and diagnose problems within the current TMF, as well as support the clinical operations team to implement new eTMF and coordinate activities for best practices.
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 emerging biotechnology company, located in North Carolina, to provide regulatory strategy expertise by crafting the regulatory process and internal planning for an upcoming IND submission, and performing several tasks including conducting background research into what type of testing and controls are needed to maintain…
BioBridges has been engaged by an emerging, Boston-based, biopharmaceutical company to provide clinical trial management expertise by overseeing internal cross-functional study teams, as well as getting sites initiated, reviewing operational contracts, and engaging in PI interaction for patient identification and selection.
BioBridges has been engaged by an established biotechnology company, located in North Carolina, to provide clinical trial expertise to support a clinical operations team prepare for an FDA pre-approval for an NDA submission.