https://shekharchalwadigrepo-hub.r-universe.devRecent package updates in shekharchalwadigrepo-hubR-universehttps://github.com/shekharchalwadigrepo-hub.pnghttps://shekharchalwadigrepo-hub.r-universe.devMon, 12 Oct 2026 10:00:22 GMTskrchalwadicg@gmail.com (Shekhar Eranna Chalwadi)Validates clinical and nonclinical study-data packages against publicly described FDA technical-rejection criteria, SAS XPORT constraints from the Study Data Technical Conformance Guide, and an extensible catalog of SDTM, SEND, and ADaM structural conformance checks. Reads a study folder of CSV, RDS, or (when the suggested package haven is installed) SAS v5/v8 transport files, optionally checks define.xml, and writes a submission-style HTML and CSV validation report. This package is an independent open-source implementation. It is not affiliated with, endorsed by, or a copy of Pinnacle 21, Certara, or the FDA.https://github.com/r-universe/shekharchalwadigrepo-hub/actions/runs/39764937234Mon, 12 Oct 2026 10:00:22 GMTopenstudyval0.1.1successhttps://shekharchalwadigrepo-hub.r-universe.devhttps://github.com/shekharchalwadigrepo-hub/openstudyvalvalidating.Rmdvalidating.htmlValidating an FDA study-data package2026-10-12 07:06:512026-10-12 07:06:51skrchalwadicg@gmail.com (Shekhar)Builds submission-style efficacy and safety figures used in clinical review packages, with one simulator for each therapeutic area. Oncology figures include Kaplan-Meier curves, RECIST waterfalls, swimmer plots and spider plots. Cardiovascular, endocrine, immunology, infectious disease and neuroscience figures include time-to-event curves, mean change from baseline and responder rates. Shared safety figures include an adverse-event dot plot, an eDISH liver plot, a laboratory shift plot and an exposure plot. Reference lines follow RECIST 1.1 and the FDA drug-induced liver injury guidance. This is not an FDA product and does not guarantee regulatory acceptance.https://github.com/r-universe/shekharchalwadigrepo-hub/actions/runs/38878368025Sat, 03 Oct 2026 04:31:57 GMTtrialfigs0.1.0successhttps://shekharchalwadigrepo-hub.r-universe.devhttps://github.com/shekharchalwadigrepo-hub/trialfigs