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Open source tools offer easier access to leading edge methods than ever before, but with that comes new risks of code quality that aren't addressed by familiar regulated industry practices. At the R Validation Hub, we offer the R package riskmetric to help bridge that gap. The package provides a platform for quantifying the quality of an R package, supporting risk-based validation of software opening the door for faster and more dynamic incorporation of open source tools into regulatory analysis.
We will give a walkthrough of the riskmetric package, highlighting potential use cases ranging from scientific end users to systems administrators, and discuss how the package contributes one piece of the R Validation Hub's software strategy for advancing the role of open source tools in the biopharmaceutical clinical development process.
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