• A Tactical Approach To Risk Management At The System-Level

    Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type practice — which is then filed away, never to be utilized again.

  • 4 Key Ingredients Of A Robust Risk Management Framework

    It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.


Megan Marshall

Megan Marshall has concentrated experience in quality assurance and clinical diagnostics focusing in immunology and infectious disease testing. At Halloran Consulting Group, she is responsible for writing and evaluating procedures, identifying and executing process improvements, and assisting with CAPA development and various audits. Previously, Marshall was employed by Oxford Immunotec, where she worked as a quality assurance specialist providing support across a diverse operations group that included diagnostics, device manufacturing, and research and development. Marshall was a team member responsible for obtaining FDA (CBER) licensure for a biologic used in the screening of donated blood units for the detection of tick-borne parasite Babesia microti.