Glossary for Open Source Drug Development efforts
{falcon}
The {falcon} initiative is an industry collaborative effort under {pharmaverse} that unites Boehringer Ingelheim, Moderna, Roche, and Sanofi with the aspiration of building and open-sourcing a comprehensive catalog of harmonized tables, listings, and graphs (TLGs) for clinical study reporting. Drawing inspiration from the FDA Standard Safety Tables and Figures Integrated Guide (https://downloads.regulations.gov/FDA-2022-N-1961-0046/attachment_1.pdf), the {falcon} initiative has successfully developed and open-sourced 11 templates to date.
https://pharmaverse.github.io/falcon/
Nest
A set of R packages for streamlining the generation of interactive analyses. NEST is a software development project for creating R-based tools to analyze clinical trial data for exploratory and regulatory use.
https://insightsengineering.github.io/nest/
OAK
An open-source community project to evolve software that uses agnostic transformation logic to enable mapping of CDASH to SDTM whose functionality will also generate raw synthetic data. Roche’s solution for automating STDM mapping.
https://www.cdisc.org/oak
TLG Catalog
A catalog of Tables, Listings, and Graphs output produced by NEST tools.
https://insightsengineering.github.io/tlg-catalog/stable/