Did you know that only 50% of NME applications are approved on first submission to the FDA and there is a median delay of 435 days to approval following the first unsuccessful submission?
Explore our on-demand webinar on The Importance of Quality Data and Data Fitness in a Regulatory Submission. In this webinar, our presenters will provide guidance and support for those preparing a submission of their Investigational New Drug (IND) to regulatory bodies. In this webinar together we will explore:
- Study Data Conformance
- Data Quality Oversight
- Statistical Review of Common Reasons for Submission Failure
- CDISC and eCTD review
- Risk-based approaches to Monitoring
- Statistical Approaches and Inferential Conclusions