About Us

The main challenge of using R in late-phase trials is ensuring validation documentation. In June 2018, the R-Consortium awarded funding to create an online repository for R package validation in accordance with regulatory standards.

We focus on designing a framework that assesses the quality of an R package.

R Validation Hub: Mission

R Validation Hub is a collaboration to support the adoption of R within a biopharmaceutical regulatory setting

Current Executive Committee

R Validation Hub is governed by an executive committee. Here is the committee, as of May 2022:

  • Andy Nicholls (Chair)
  • Lyn Taylor (Secretary)
  • Joe Rickert (R Consortium)
  • Juliane Manitz
  • Doug Kelkhhoff
  • Paulo Bargo
  • Preetham Palukuru
  • Eric Milliman
  • Aaron Clark

Thank you to previous committee members for helping to drive the R Validation Hub forward:

  • Marly Gotti
  • Yilong Zhang
  • Keaven Anderson
  • Min Lee

Participating Organisations

The R Validation Hub comprises of participants from across the pharmaceutical industry. Participants contribute to the effort through our regular group meetings, as well as the various workstreams that make up the project. If you are interested in getting involved please contact psi.aims.r.validation@gmail.com. Else you can sign up to our mailing list here.

If you are a member and your organisation does not appear on this list, please let us know!

  • Abbvie
  • Acerta Pharma
  • Amgen
  • Astellas
  • Atorus Research
  • Bayer
  • BeiGene
  • Biogen
  • BioMarin Pharmaceutical Inc.
  • Boehringer-Ingelheim
  • BresMed
  • Celgene
  • ClinBAY
  • Cognigen Corporation
  • Eli Lilly
  • FDA
  • Galapagos NV
  • Genentech
  • Gilead
  • GSK
  • HMS Analytical Software
  • InModelia
  • Johnson & Johnson
  • Kite Pharma
  • Linux Foundation
  • Merck KGaA/EMD Serono
  • MSD
  • Novartis
  • Novonordisk
  • Nuventra
  • Parexel
  • Pfizer
  • Phastar
  • PPD
  • Quanticate
  • RCPE
  • Rho, Inc.
  • Roche
  • RStudio
  • Sanofi
  • Scharp
  • Servier
  • SQN Clinical
  • Teva Pharmaceutical Industries Ltd.
  • University of Sheffield

Independent consultants

  • Parker Sims