AI-Powered • Dual R/Python • 21 CFR Part 11 • CDISC Native

Your AI Statistical Computing
Workspace

Analyze data, write and execute R and Python, build publication-quality visualizations, and perform clinical research analysis, all in one intelligent workspace.

R Python Statistics Data Science Biostatistics Clinical Trials AI
7
Integrated Studios
30+
Specialized Tools
100%
21 CFR Part 11 Compliant
R + Py
Dual-Language Engine
AI
RPWisdom AI Copilot
Platform Overview

7 Integrated Studios in One Workspace

Each studio is purpose-built for a different aspect of statistical computing and clinical research, seamlessly connected through a unified interface.

Core Capabilities

Everything You Need for Modern Statistical Computing

From AI-powered code generation to GxP-validated clinical deliverables, every feature is engineered for rigor, speed, and compliance.

🤖

RPWisdom AI Copilot

Intelligent coding assistant that understands R, Python, and clinical biostatistics. Ask questions in plain English and get production-grade code with explanations. Supports multi-turn conversations with full context awareness.

⚡

Dual R & Python Engine

Native R process (R 4.6.1) and Python (3.12) execution side-by-side with full package ecosystems. Switch seamlessly between languages with shared data context and in-memory DuckDB for zero-latency clinical transformations.

📊

ICH E3 Table 14.x Builder

Auto-generate Table 14.1.1 demographics, safety AE tables, lab shift matrices, and efficacy summaries with population filters (ITT, Safety, Per-Protocol). Export directly to Word/PDF for CSR appendices.

📈

Interactive Plot Canvas

Drag-and-drop visual builder generating live ggplot2 and Seaborn/Matplotlib code. Create Kaplan-Meier curves, swimmer plots, forest plots, box plots, and more with interactive hover inspection.

🏊

ADTRBC Swimmer Plot Studio

Interactive patient-level tumor burden tracker with RECIST 1.1 milestones: complete response (CR), partial response (PR), stable disease (SD), and ongoing treatment markers.

🔒

21 CFR Part 11 Database Lock

Cryptographic SHA-256 database lock ceremony with legally binding electronic signatures, tamper-evident audit logs, non-repudiation PIN signing, and downloadable TMF certificates.

⚖️

Dual-Programmer Blind Validation

Automated double-programming comparison between R primary scripts and SAS/R QC code with configurable floating-point tolerances (1e-4 to 1e-8). Generates reconciliation certificates.

📋

Protocol & SAP Authoring

Interactive SAP designer with BOIN dose-escalation algorithms, ICH E9(R1) estimand framework, regulatory templates, AI drafting copilot, and full amendment tracking.

📝

Quarto & R Markdown Reports

Full-featured Quarto/Rmd authoring environment with live preview, parameterized regulatory reports, and one-click rendering to HTML, PDF, Word, and PowerPoint for CSR dossiers.

📓

Polyglot Inline Notebook

Cell-by-cell interactive notebook supporting both R and Python in the same document. Execute, visualize, annotate, and share analyses with rich markdown cells and code outputs.

📂

Project Management

Kanban deliverables board, Gantt charts, budget tracking, delay monitoring, and study timeline management. Keep clinical programming teams aligned and on schedule.

🎯

CDISC ADaM/SDTM Native

First-class support for ADSL, ADAE, ADLB, ADTTE, and ADTRBC domains. Built-in CDISC variable dictionaries, derivation traceability, and Pinnacle 21 validation integration.

Clinical & Statistical Tools

30+ Specialized Tools at Your Fingertips

Access every tool you need for clinical programming, regulatory submission, and statistical analysis, all integrated directly into the studio.

⚡

R Runtime Connection

Live R execution environment with path scanner and system diagnostics

R 4.6.1
📦

renv Package Lock Manager

GxP reproducible dependency snapshots via Posit Package Manager

GxP
📝

Code Snippets Library

Validated clinical biostatistics and TLF templates for R and Python

Library
📄

CRF & aCRF Studio

Visual annotation mapping clinical variables to CDASH and SDTM domains

SDTM
✨

Protocol-to-Code AI

Upload protocol or SAP to synthesize production-grade R/Python code

AI Engine
📥

Export Dossier (Word/PDF/PPTX)

Compile tables into unified CSR Section 14 appendices and eCTD modules

CSR 14.x
🛡️

CDISC / Pinnacle 21 Validator

Automated FDA rejection rule compliance with auto-remediation suggestions

Pinnacle 21
✅

Dual-Programmer QC Validation

Blind double-programming reconciliation and statistical output diff engine

Validation
⏰

Scheduled Reports / Auto-Run

Cron batch pipelines, scheduled execution and automated report delivery

Automation
👥

Multiplayer Collaboration

Live dual-programmer pair coding and biostatistical study chat

Live
⏱️

Script Time Machine

Chronological code snapshots, revision timeline, and one-click rollback

Audit
🗄️

Database & SAS Connectivity

SAS7BDAT, SQL databases, EDC interfaces, and S3 cloud data lakes

Data Lake
🤖

AI Protocol & Regulatory Advisor

ICH E9(R1) estimand extractor, power calculator, and statistical advisor

ICH E9(R1)
🔐

21 CFR Part 11 Database Lock

Electronic signature and cryptographic study freeze for database lock

21 CFR 11
📑

ADRG v1.2 Auto-Compiler

Analysis Data Reviewer's Guide auto-compiler for eCTD Module 5.3.5.3

eCTD
🏃

Patient Journey Timeline

Multi-domain chronological event timeline (ICH E3 Fig 14.3.1)

ICH E3
💬

Feedback & Bug Reporting Desk

Submit feedback, report issues, and track responses from the engineering team

Support
⚙️

Menu & Navigation Management

Admin-level control to show/hide any studio tabs, tools, or menus

Admin
Regulatory & Compliance

Built for FDA, EMA & PMDA Submissions

Every tool meets strict pharmaceutical regulatory requirements out of the box, with no additional validation needed.

🔒 FDA 21 CFR Part 11

Full electronic records and signatures compliance with cryptographic integrity.

  • SHA-256 cryptographic database lock ceremony
  • Legally binding electronic signatures (non-repudiable)
  • Tamper-evident comprehensive audit trail
  • PIN-authenticated attestation ceremonies
  • Downloadable TMF certificates

📋 CDISC Standards

First-class support for all major CDISC data standards and dictionaries.

  • ADaM domains: ADSL, ADAE, ADLB, ADTTE, ADTRBC
  • SDTM Implementation Guide v3.4
  • CDASH v2.2 eCRF variable mapping
  • Pinnacle 21 integrated validation
  • Automated derivation traceability

📊 ICH E3 & E9

End-to-end support for ICH guidelines throughout the study lifecycle.

  • Table 14.x auto-generation (demographics, safety, efficacy)
  • ICH E9(R1) estimand framework integration
  • ICH E6(R2) Good Clinical Practice
  • CSR Section 14 appendix compilation
  • eCTD Module 5.3.5.3 export

⚖️ GxP Reproducibility

Every result is reproducible, auditable, and traceable from protocol to submission.

  • renv deterministic package locks
  • Posit Package Manager snapshots
  • Dual-programmer blind validation (tolerances 1e-4 to 1e-8)
  • Script Time Machine with revision history
  • Docker containerized deployments (pinned R versions)
Live Interactive Widget

Try the 21 CFR Part 11 Digital Lock Ceremony

Experience the cryptographic database lock process. Enter your credentials to generate an immutable SHA-256 digital signature.

Cryptographic Digital Attestation Result:
STATUS: READY TO SEAL
ALGORITHM: SHA-256 HMAC (21 CFR Part 11)
TARGETS: ADSL.csv (239) • ADAE.csv (480) • ADLB.csv (1420)

Click "Compute Cryptographic Part 11 Seal" to execute!
Deployment

Run Anywhere: Cloud or Desktop

RPWisdom AI works as a cloud web application and as an installable desktop app via PWA. Zero installation required.

☁️

Cloud Edition

Access instantly at rpwisdom.com from any browser. Powered by Railway with auto-scaling, HTTPS, and global edge caching. No setup, no downloads.

🖥️

Desktop App (PWA)

Install as a native desktop app directly from your browser. Works offline, launches from taskbar, and receives automatic updates via service worker.

🐳

Docker / Self-Hosted

Deploy on-premises with the production Dockerfile. Includes R, Python, Node.js, and all clinical packages pre-installed. FDA-compliant containerized deployment.

Ready to Transform Your Statistical Workflow?

Access the full production environment with live R/Python terminals, AI Copilot, 30+ tools, and exportable regulatory deliverables, completely free.

Launch RPWisdom AI Studio 🚀
Open Studio