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:
EVP, Head of Statistics
Karen is responsible for overseeing the Statistics department at Quanticate. Karen is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years. Prior to joining Quanticate in 1999 (Statwood), Karen was a Senior Statistician at Unilever.
SVP Project Delivery
Santosh Tymms is a statistician at Quanticate. His role includes providing high-quality statistical support to clients, contributing to process improvement and knowledge sharing within the department and researching data quality oversight. Santosh has worked in medical statistics for 4 years following an MSc with Distinction from Lancaster University.