Open Source

We build with the open clinical software community

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.

Built and maintained here

R4SUB, our submission readiness ecosystem

R4SUB (Ready for Submission) turns the checks a team runs before a filing into reproducible R code: traceability from a value back to its source, a submission confidence score, and quantified risk across an ADaM and SDTM package. It is our own work, released under MIT, and published on CRAN so anyone can install it.

The r4sub meta-package attaches the ecosystem in one call, the way tidyverse does. Seven packages are on CRAN today and the ecosystem is still evolving, with further packages and a newer release in development.

r4subMeta

Installs and attaches the ecosystem in a single call. On CRAN at 0.1.0.

r4subcoreCore

Data contracts, parsers and the scoring primitives the others build on.

r4subtraceTraceability

Traceability engine, following a result back through to its source.

r4subscoreScoring

Submission confidence index, so readiness is a number rather than an opinion.

r4subriskRisk

Risk quantification across a submission package.

r4subprofileProfiles

Regulatory submission profiles for different filing routes.

r4subdataData

Example datasets, so the checks can be run against something before your own study.

Install with install.packages("r4sub"). Source and issues on GitHub, package pages on CRAN, development builds on R-universe.

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.

R submission pilots

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.

Contribution and qualification

We report issues, submit fixes upstream, and run the validation needed to use these packages safely inside audit ready workflows.

Packages we work with

A representative set of the open packages our teams use across data standards, reporting, and submissions.

admiralADaM

Modular, traceable creation of ADaM analysis datasets.

sdtm.oakSDTM

Builds standardized SDTM domains from collected data.

rtablesTLG

Flexible, submission grade clinical trial tables.

ternTLG

Analysis functions and standardized clinical output.

TplyrTLG

A grammar for clinical summary statistics.

tealShiny

Framework for interactive clinical data review.

xportrSubmission

Writes compliant transport files for delivery.

pkgliteSubmission

Packages R code into a submittable text artifact.

metacoreMetadata

Holds machine readable dataset specifications.

metatoolsMetadata

Utilities for working with metadata standards.

sdtmchecksSDTM

Quality checks and validation for SDTM datasets.

tidytlgTLG

Templated, 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.

Considering a move to open clinical tooling?

We can help you adopt these packages and qualify them for your validated environment.

Talk to us