Confident Delivery of Integrated Summaries

The integrated summary of safety (ISS), integrated summary of efficacy (ISE), and Study eSubmission deliverables are considered key components of a New Drug Application (NDA) for the U.S. FDA as well as other regulatory agencies around the world. Getting your study ready for eSubmission, integrating data, creating an ISS and/or ISE represents a resource-intensive undertaking with project managers, medical coders, statistical programmers, CDISC specialists, biostatisticians and medical writers. These roles are often outsourced by drug development sponsors to a contract research organization (CRO). This video discusses how Covance helps sponsors confidently deliver integrated summaries.