ARTICLES BY MEGAN MARSHALL

• Implementing QbD In Your Clinical Trial? 4 Questions To Answer First

  12/19/2019

  Quality, as it relates to clinical trials, is defined as an absence of errors that matter to decision-making. Therefore, quality by design (QbD) literally translates into an absence of errors that matter to decision-making by design. This proactive approach to quality continues to gain global and regulatory support. In fact, on May 8, 2019, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a draft revision of ICH E8 (R1), General Considerations for Clinical Studies.

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

  7/10/2019

  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.

• Implementing Risk-Based Monitoring: 6 Lessons From The Trenches

  2/26/2019

  While risk management as a concept has always played a role in the clinical trial space, there is increased pressure to identify and manage trial-related risks more systematically. This article discusses six important considerations when making the decision to utilize RBM as part of your operational growth strategies.