Enabling Confident Delivery of Integrated Summaries for New Drug Applications

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. Learn how Labcorp FSPx can support your data conversation across multiple study data tabulation methods (SDTMs), validation and reporting for submission.