Real-World Evidence & Data

The Ultimate Nexus of
Evidence & Intelligence

The definitive ecosystem for Real-World Evidence and Real-World Data. Unified knowledge architecture merging rigorous methodology with AI-driven infrastructure.

The Evidence Mastery Book Series

Five volumes covering the full spectrum of Real-World Evidence — from foundational principles to advanced causal methods and clinical context.

Vol 1May 2026
Volume 1
Principles and Practice
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Vol 2Dec 2026
Volume 2
Sources and Solutions
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Vol 3May 2027
Volume 3
Tools and Templates
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Vol 4Dec 2027
Volume 4
Methods and Mastery
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Vol 5Soon
Volume 5
Diseases and Drugs
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Evidence Mastery Academy

A structured progression from foundational literacy to advanced executive methodology.

📚
Physical Library

The complete 5-volume professional curriculum for RWE practitioners and leaders.

🎧
Audiocourses

Immersive audio adaptations of each volume — deep-dive into the curriculum as a standalone resource or as a companion to the physical books.

🎬
Video Masterclasses

High-level digital learning modules adapted directly from the book chapters.

Explore the Academy Ecosystem →
Dr Massoud Toussi
VP, Real-World Evidence — UBC
MD, PhD, MBA
50+ peer-reviewed publications
HTAi • ISPOR • EU2P • ENCePP
5 continents of RWE leadership

Massoud Toussi,
MD, PhD, MBA

Dr Massoud Toussi is a globally recognised authority in Real-World Evidence and Real-World Data, with over 20 years of leadership across pharmaceutical, CRO, regulatory, and non-profit organisations. As Vice President of Real-World Evidence at United Biosource Corporation (UBC), and formerly VP and Global Head of RWE at Cytel and Global Category Lead at IQVIA, he has led hundreds of multinational studies and shaped evidence generation strategy across five continents.

The author of five books on real-world evidence and data, Dr Toussi has published 50+ scientific papers, contributed to major guidelines, and held leadership positions at HTAi, ISPOR, EU2P, and ENCePP. He reaches an engaged professional community of 11,000+ through his LinkedIn network and his newsletter, Evidence Mastery.

Evidence Mastery was created to bridge the gap between scientific rigour and practical application — aggregating knowledge, tools, and training for the global RWE community.

Next-Gen RWE Infrastructure

EvidenceAi™ Suite

A unified ecosystem of specialised modules designed to accelerate evidence generation while maintaining rigorous regulatory compliance.

A Clear Eye on RWE Guidelines
Guide Ai
RWE Guideline Intelligence

Navigate the complete library of RWE guidelines, regulatory frameworks, and reporting standards — curated, cross-referenced, and searchable.

EMA / FDAHARPERSTROBE
BrowseFilterReference
An Eagle Eye on RWD Sources
Explore Ai
RWD Knowledge Infrastructure

Search and explore the most comprehensive global directory of RWD sources curated by Evidence Mastery.

300+ Sources50+ Countries
SearchFilterFind Database
A Visionary Eye to Transform Ideas
Concept Ai
AI Study Concept Generator

Transforms plain language ideas into stakeholder-adapted study concept sheets grounded in HARPER.

HARPER 2023Word Download
Describe IdeaAI BuildDownload
A Sharp Eye to Find Fit-for-Purpose Data
Feasibility Ai
RWD Feasibility Intelligence

Upload a protocol to extract PICOTS elements and generate a feasibility report against EMA/FDA frameworks.

PICOTSCSV Matrix
ProtocolMatchingFeasibility
An Expert Eye to Build Your Protocol
Protocol Ai
AI Protocol Generator

Generates a full HARPER-compliant non-interventional study protocol section-by-section.

ICH M14Word Doc
Upload RFPExtractionGenerate
A Statistical Eye to Architect Analysis
SAP Ai
AI SAP Generator

Generates a regulatory-grade SAP with methodology sections and TFL shells.

ICH E9(R1)JAMA 2017
ProtocolBlueprintDownload
From SAP to Production-Ready Code
Code Ai
AI Statistical Code Generator

Generates fully-documented programming packages in R, SAS, or Python adapted to your data model.

OMOP CDMZIP Archive
Upload SAPSelect LangZIP
Coming Soon
A Precision Eye on Data & Analysis
Data & Analyze Ai
Data Preparation & Analysis Engine

Prepare, clean, and structure patient-level data — then execute primary and sensitivity analyses with output-ready tables, figures, and listings aligned to your SAP.

OMOP / FHIRR / SAS / PythonTFL Output
Link DataRun PipelineTFL Results
A Scientific Eye for Final Evidence
Report Ai
AI CSR Builder

Synthesises protocol and statistical results into a complete Clinical Study Report — GVP Module VIII, RECORD-PE, and STROBE aligned.

GVP Module VIIIRECORD-PEWord + Tables
Upload ProtocolUpload TFLsFull CSR
A Narrative Eye for Global Publication
Manuscript Ai
AI Publication Architect

Tailors your study report into a publication-ready manuscript draft specific to your target journal’s guidelines.

ICMJESTROBERECORD-PE
Select JournalMap RulesDraft
A Regulatory Eye on Your Dossier
Assess Ai
Regulatory & HTA Dossier Assessment

Assesses your dossier from the perspective of your selected regulatory or HTA body — probability of success, major and minor comments, and a prioritised action plan.

EMA · FDA · NICEHAS · G-BAWord Report
Upload DossierSelect BodyAssessment
An Intelligent Eye to Appraise Manuscripts
Appraise Ai
RWE Acceptability Intelligence

Performs rigorous first-pass peer review across 8 domains covering methodology and bias assessment.

Quality ScoringCrossRef
UploadAppraisalReport
Volume 1 — Now Available

The Scientific Tango

Audio Companion to Real-World Evidence: Principles & Practice

Eighteen in-depth conversational sessions where two world-class experts dissect every chapter of the book — in a format that makes the science genuinely engaging. Thirteen hours of expert audio that fits around your schedule.

  • 18 sessions covering the full RWE lifecycle — from principles to regulatory strategy
  • Topics include bias & confounding, HTA frameworks, regulatory decision-making, and the future of RWE
  • Stream any time, any device — lifetime access, no subscription
  • PDF companion guide included with purchase
  • Free preview — Course introduction available without account
🎧 13h+ of expert audio 18 sessions Regulatory & HTA Bias & confounding RWE strategy Digital health
Explore all sessions →
One-time purchase
Lifetime access

Start listening today

By Dr Massoud Toussi, MD, PhD, MBA. The companion that turns the book into a conversation — designed for scientists who think best on the move.

🎧 Get Instant Access ▶ Listen to free preview — no account needed
Instant access after purchase
Secure checkout via Stripe
PDF companion guide included

Executive Masterclasses