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The objectives of the R Consortium R Submission Pilot 3 Project are:

  1. Deliver a publicly accessible R-based Submission through the eCTD portal
  2. 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.

What’s on the Website?

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:

  1. Project Background/Setup - Scope of work, what we used and how we used it.
  2. Deliverables - What was sent to the FDA - Cover Letter, TLFs, Datasets, ADRG.
  3. Conferences - Proceedings from different conferences on Pilot Submissions
  4. WG Minutes and Regulatory Feedback - Provides a menu of links in two sections.
    • Section 1: Provides links to the monthly WG Meeting Minutes
    • Section 2: Provides a link to the Pilot3 Team Compilation of the Regulatory Review - Pilot3 Team Interpretation(s) of the Regulatory Feedback (FDA Review Continues)

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Get in Touch

Don’t be shy! We like to chat about R and Submissions. Find us on pharmaverse slack