When applied to clinical development, Quality by Design is an approach that focuses effort on prospectively identifying and managing risk to improve clinical trial quality and outcomes. The application of Quality by Design principles is particularly important in rare diseases, where the limited, geographically-dispersed, and often vulnerable patient pool leaves little margin for error. By...
Quality and effective risk management are vital to every clinical trial, and their importance is greater still when working in rare indications. Your patient population is small, vulnerable, and geographically dispersed, so there’s limited data and little opportunity to replicate clinical trial results. It’s as if the phrase “get it right the first time” had...
Nicky Dodsworth, Vice President for Global Quality Assurance at Premier Research, will address those and other questions Oct. 13 when she presents The Protocol and QbD at the European Forum for Good Clinical Practice’s Risk-Based Management of Clinical Trials workshop in Prague. Dodsworth’s presentation at 11:30 will set the scene for the event’s afternoon session on understanding and assessing risks in a sample protocol.