Christine Quagan, Senior Medical Writer, PROMETRIKA, LLC
Recently, the Medical Writing Team at PROMETRIKA completed our second New Drug Application (NDA) submission within a year. The process of developing the suite of documents for each submission – including the integrated summaries (ISS and ISE), clinical summaries (SCS and SCE), and clinical overviews (COS and COE) of safety and efficacy – involved much collaboration among the writers, biostatisticians, and the sponsors’ clinical development teams. Without it, the team would not have been able to meet the tight submission timelines set by the sponsors.
With our experience fresh in our minds, we read the article “A Pilot Survey of Strategies for the Development of Clinical Summary Documents” in a recent issue of the American Medical Writers Association Journal. How similar was our experience to other writers who developed submission documents? Continue reading “The Best Way to Develop Regulatory Submission Documents? Survey Says . . .”