cdisc

ADaM in R Asset Library

Admiral Package Extension for Pediatric Clinical Trials

An R package for standard adverse events analysis

Clinical trial analysis end to end in R: SAP, CDISC ADaM with admiral, TLFs, XPT, competing risks, independent double programming, and validation against a published trial

Clinical reporting pipeline in R on the public CDISC pilot study with pharmaverse: ADaM datasets (ADSL, ADAE, ADTTE), Kaplan-Meier and Cox regression, QC against reference datasets and second derivations

Lindus Health — independent third-party profile of a public API surface, by API Evangelist. Lindus Health is a next-generation contract research organization (CRO) that runs clinical trials end to end for biotech and pharmaceutical sponsors. It pairs Citrus, an AI-assisted trial operating system connecting patient identification through final data

Astraea — independent third-party profile of a public API surface, by API Evangelist. Astraea is a Y Combinator-backed (Spring 2026) clinical trial automation platform that gives pharmaceutical sponsors, biotechs, and CROs an AI operating system for clinical development.

Clinical Data Research Navigator helps researchers turn clinical-data questions into source-ranked evidence, a safe data contract, and an explicit execution maturity assessment.

An open-source, local-first Model Context Protocol (MCP) server written in TypeScript for **Biopharma Software Infrastructure, FDA 21 CFR Part 11 GxP Audit Trailing, CDISC SDTM/Allotrope Data Exports, 4PL Dose-Response Curve Fitting, and HIPAA PII/PHI Redaction**.

Clinical evidence console and FHIR warehouse with CDASH metadata, executable validation, SDTM mapping, coding, sourced operational measures, and reproducible SQL Server evidence.

End-to-end clinical trial programming (raw → SDTM → ADaM → TLF) on CDISC Pilot data, dual-implemented in SAS and R. For learning/portfolio purposes only; not related to any regulatory submission.

Clinical R in Practice — free Quarto book on the open-source R stack behind regulated drug development: pharmaverse, ADaM, ARD, validation, LLM agents. 15 chapters, 5 parts.

Turn CDISC SDTM PDFs into an AI-ready searchable knowledge base — 293 structured Markdown files, 63 domains, 37,939 terminology terms

Config-driven clinical trial ETL pipeline: Excel mapping → CDISC SDTM datasets + M5 regulatory submission package

Top Clinical Data Management (Opensource) 🌟 Star if you like it! 🌟

Transforms IDDO customised SDTM domains into analysis datasets

Use R to get R — translate SAS to R with a coordinated multi-agent workflow, built for clinical programming

Config-driven Python pipeline that produces SDTM datasets, plus a Rust CLI that writes SDTM dataset-specification workbooks from them