Site startup for a clinical trial will always be a challenge. Why? While driving the study forward and gathering cross-functional expertise to operationalize a successful study, site startup is comprised of many unexpected hurdles that may get in the way of meeting clinical development milestones.  Site activation is not an easy or rapid process. Based […]

As a panelist at CORE (Clinical Operations Retreat for Executives) East, hosted in Chatham, Massachusetts, I had the privilege of participating in a lively discussion on the theme of driving change with a patient-centric focus. This session brought together a remarkable group of experts advocating for early patient engagement throughout the entire clinical development process, […]

Planning, assembling, and editing a Chemistry, Manufacturing, and Controls (CMC) dossier is a critical part of every clinical trial application and marketing authorization submission. Every CMC dossier requires the compilation of copious amounts of data from various departments (i.e., Research and Development, Manufacturing, and Quality). Regulatory and technical authors must then summarize these data according […]