The objectives of the R Consortium R Submission Pilot 3 Project are:
- Deliver a publicly accessible R-based Submission through the eTCD portal
- Expand on the work done in Submission Pilot 1, by now utilizing R to generate ADaM datasets.
NOTE: This is a FDA-industry collaboration through the non-profit organization R Consortium.
This website encapsulates the hard-work of some intrepid statistical programmers from across the Pharma Industry to demonstrate a R-based Submission to the FDA.
The website is divide into 4 sections that will walk you through our efforts:
- Project Background/Setup - Scope of work, what we used and how we used it.
- Deliverables - What was sent to the FDA - Cover Letter, TLFs, Datasets, ADRG.
- Conferences - Proceedings from different conferences on Pilot Submissions
- FDA Feedback - Specific feedback from FDA on this Submission
- Data scientists at Novo Nordisk, a leading pharmaceutical company in diabetes, obesity, and other chronic diseases, share details of their first FDA submission package featuring outputs and ADaM datasets written exclusively in R.
Don’t be shy! We like to chat about R and Submissions. Find us on pharmaverse slack