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BioBridges | Experience That Works

Avatar by Amy Steinberg · Published Jul 22, 2020 · Last updated Jul 22, 2020

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 | Experience That Works

Avatar by Amy Steinberg · Published Jul 20, 2020 · Last updated Jul 20, 2020

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 | Experience That Works

Avatar by Amy Steinberg · Published Jul 17, 2020 · Last updated Jul 17, 2020

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 | Experience That Works

Avatar by Amy Steinberg · Published Jul 16, 2020 · Last updated Jul 16, 2020

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 | Experience That Works

Avatar by Amy Steinberg · Published Jul 13, 2020 · Last updated Jul 13, 2020

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 | Experince That Works

Avatar by Amy Steinberg · Published Jul 10, 2020 · Last updated Jul 10, 2020

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 | Experience That Works

Avatar by Amy Steinberg · Published Jul 8, 2020 · Last updated Jul 8, 2020

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 | Experience That Works

Avatar by Amy Steinberg · Published Jul 6, 2020 · Last updated Jul 6, 2020

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 | Experience That Works

Avatar by Amy Steinberg · Published Jul 2, 2020 · Last updated Jul 2, 2020

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 | Experience That Works

Avatar by Amy Steinberg · Published Jul 1, 2020 · Last updated Jul 1, 2020

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.