by Amy Steinberg 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.
BioBridges has been engaged by an emerging biopharmaceutical company, located in New York, to provide human resource expertise by engaging in contract review, including reviewing employee contribution and overall costs, reviewing benefit summary documents, and discuss vesting change to 401k.
BioBridges has been engaged by an established biotechnology company, located in the Boston area, to provide program management expertise to lead development and drive execution of program work plans, timelines and integrate activity plans with milestones, goals, key events, risks and assumptions.
BioBridges has been engaged by an established biopharmaceutical company, located in California, to provide clinical medical writing expertise to develop a clinical phase protocol for a drug-drug interaction study.