The pharmaverse
A curated set of packages covering the path from raw data to clinical reporting. It lets sponsors collaborate on shared tooling instead of each rebuilding the same components.
The packages that produce clinical datasets, reports, and submissions are increasingly open and shared across the industry. We adopt them, contribute to them, and qualify them for regulated work.
A curated set of packages covering the path from raw data to clinical reporting. It lets sponsors collaborate on shared tooling instead of each rebuilding the same components.
The R Consortium submission working group has run a series of pilots with the FDA, delivering tables, datasets, and interactive review applications through the electronic gateway.
We report issues, submit fixes upstream, and run the validation needed to use these packages safely inside audit ready workflows.
A representative set of the open packages our teams use across data standards, reporting, and submissions.
admiralADaMModular, traceable creation of ADaM analysis datasets.
sdtm.oakSDTMBuilds standardized SDTM domains from collected data.
rtablesTLGFlexible, submission grade clinical trial tables.
ternTLGAnalysis functions and standardized clinical output.
TplyrTLGA grammar for clinical summary statistics.
tealShinyFramework for interactive clinical data review.
xportrSubmissionWrites compliant transport files for delivery.
pkgliteSubmissionPackages R code into a submittable text artifact.
metacoreHolds machine readable dataset specifications.
metatoolsUtilities for working with metadata standards.
sdtmchecksSDTMQuality checks and validation for SDTM datasets.
tidytlgTLGTemplated, end to end table and figure production.
Open packages need qualification before they can be trusted in a filing. We pair adoption with validation, so the tooling carries the evidence a regulated process requires.
We can help you adopt these packages and qualify them for your validated environment.
Talk to us