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[On-Demand Webinar]

The Importance of Quality Data and Data Fitness in a Regulatory Submission

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

Download our On-demand Webinar

Meet the Panelists

Karen Ooms-1

Karen Ooms

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.


Paula Finch

SVP Project Delivery

Paula has been in the industry for over 20 years as both a statistician and a SAS programmer, working for pharma and CROs, after graduating with a BSc Mathematics and MSc Applied Statistics. She joined Quanticate at the beginning of 2019, previously Head of Phase 1 programming at Eisai. Paula oversees the project delivery for Statistics and Programming in the Fixed Fee department for Quanticate.

Santosh_clipping mask

Santosh Tymms

Statistician I

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.