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Learn to Apply R in the Regulatory Submission Process (Join Us)
Pharmaverse: Metadata > OAK > Admiral > Define.xml > TLGs (rtf/pdf) > Submissions > Shiny
R Scripts: Logs (logr), Scan Logs
| R Package |
Metadata |
Raw to SDTMs |
To ADaMs |
To Tables, Lists and Graphs |
|
R Scripts (Tidyverse, DPLYR, etc.) |
N/A | R Scripts | R Scripts |
R Scripts: Statistical Analysis |
|
Pharmaverse |
SAS & R: Software Verification ensure requirements are met
SME: Validation ensure software meets intended use and performs correctly
SCE (Software Computing Environment): Audit Trial, Version Control of Dev. & Production
SDLC & SAS Macro Programs: Specifications, Dev., Test & Document
GXP Validation of R Packages, Functions and SAS Reproduce Results with a Moving Target: Custom and Dependent R Packages
The pharmaceutical industry has quickly adapted to embrace R! The Pharmaverse concept is created as a collaboration among top pharma and industry organizations for open-source solutions. Organizations now have the option to continue programming in R using common packages or use the packages from Pharmaverse to get a jump start. With Pharmaverse R package compliance standards, organizations can feel more confident to apply these packages. Smarter organizations make time to confirm packages behave as expected with expected results. Up to 50% of Pharmaverse is built using Tidyverse. This page is designed to help guide you using Pharmaverse packages.
Pharmaverse has R packages that work as modules to help in the CDISC submission process. Organizations can plan to understand and start to incoporate R packages as needed to grow. See new to clinical data and new to CDISC to learn about the basics. Note that the SDTMs and ADaMs pages within R-Guru utilize base R and other non-Pharmaverse packages. See the pharmaverse page for information on OAK and Admiral.