Submission publishers face a number of challenges as they perform the day-to-day tasks associated with compiling and inspecting the quality of an eCTD. Innovations in technology are easing the burden in terms of actions publishers must perform manually.
Streamlining publishing tasks saves time, effort, resources and in the end, produces a higher-quality submission. Susceptibility to error is a corollary to the number of labor-intensive, manual actions performed by your publishing team. Manual processes also extend the publishing time frame, induce extra effort and require greater resources for quality assurance.
When investigating publishing solutions, organizations should ideally target vendors that substitute time-consuming processes with accurate automation. Here is a chart of the tasks technology is streamlining:
Editor’s Note: The author is a Sr. Regulatory Submission Specialist for GlobalSubmit. She has more than a dozen years of experience in electronic regulatory submission (eCTD and NeeS) publishing to various agencies including the FDA, Health Canada and EMA. Prior to joining GlobalSubmit, she represented both Clinical and Regulatory Operations in the implementation of the Trial Master File Document Management System (FirstDocs) and the upgrade to Global Electronic Library/Submission Build software (NextDocs and eCTD Xpress).