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Recent blog posts

Summary of 2022 Case Studies

By Juliane Manitz on March 15, 2023

Last year, the R validation hub recently initiated a three-part presentation series on case studies in which eight pharmaceutical companies shared their experiences on building a GxP framework with R. These case studies highlighted both easy and challenging aspects of implementing risk assessment for R packages in a GxP environment. In this blog post we attempt to summarize common themes, difference in approaches, and challenges. All implementations followed the risk validation process for R packages outlined in the white paper.

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ASA Biopharmaceutical report, Fall 2022

By Andy Nicholls on December 5, 2022

I’m pleased to share that the R Validation Hub’s efforts have been recognised in the ASA Biopharmaceutical report, Fall 2022. Within the edition you can find our paper, Risk Assessment of R Packages: Learnings and Reflections. This paper reflects on our white paper; provides an overview of our {riskmetric} package and Risk Assessment application; and summarises our 2022 case studies (which you can now find on our Case Studies page).

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Status Update May 2022

By Juliane Manitz on May 20, 2022

It’s time to bring another update to you on the current status of the R validation hub: The riskmetric R package has been stable on CRAN. Recent work has focused on structuring “cohort metrics” – metrics that are conditioned on the package library or execution environment available to R. In R, package behaviors are often dependent on the rest of the R installation, and this new feature will help to make metrics more inspectible and reproducible, as well as allowing us to ask new questions like, “What would be the effect of installing a new package into an R environment?

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Risk Assessment App Update

By Joseph Rickert on February 3, 2022

This is a re-post. The original post from the R Consortium can be found here Recent update by Marly Gotti on the Risk Assessment Shiny App. Marly is an executive committee member of the R Validation Hub where she advocates for the use of R within a biopharmaceutical regulatory setting, and Senior Data Scientist at Biogen. The Risk Assessment App is an interactive web application serving as a front end application for the riskmetric R package.

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Participating Organisations

Members of the following organisations are participating in this project