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.

Filed In

Functional Service Provider (FSPx)
Mgmt Monitoring & RBM
Stage (Late, PhIIb-III)