— Professional Certification in Real-World Evidence & Real-World Data

Real-World Evidence & Real-World Data Professional Certification

Build the Real-World Evidence skills sponsors, biotechs, payers, and health systems are hiring for — including registry-based studies and observational research — taught the way the industry actually practices it.

Real-World Evidence (RWE) and Real-World Data (RWD) have become core to how new therapies are developed, approved, reimbursed, and delivered to patients. Sponsors, biotechs, CROs, payers, health systems, and ministries of health are actively expanding RWE teams — and qualified professionals remain in short supply across every major market.
Empty space, drag to resize

Course Description

This Professional Certification prepares clinical, regulatory, and data professionals to plan, generate, and defend credible real-world evidence end-to-end. Across 17 modules — anchored to the 2025–2026 reference standards (FDA RWE Demonstration Projects, EMA DARWIN EU, ICH M14, ICH E9(R1)) — you will work through the modern RWE playbook the industry has converged on: fit-for-purpose data selection, the estimand framework, target trial emulation, synthetic and external control arms, AI-enabled methods, pharmacoepidemiology and safety signals, and the evidence packages that support regulatory submissions, HTA dossiers, payer decisions, and patient access.
The curriculum is taught with a global lens. In addition to North American and European data sources and frameworks, the program goes deep on the GCC, Africa, Southeast Asia, Latin America, and India — the regions where RWE capability is being built right now and where qualified talent is most needed.
Graduates leave with a CPD-accredited credential, a portfolio of worked artifacts (protocol, analysis plan, evidence package, capstone defense), and the vocabulary and judgment to contribute to RWE programs from day one — whether you are advancing inside your current organization or moving into your first RWE role.

Designed and delivered by faculty with 27 years of clinical research leadership across North America, the GCC, Africa, and Asia-Pacific.

17 modules — end-to-end curriculum

A structured pathway from RWE origins and the 2026 landscape through RWD source selection, modern study design, AI-enabled methods, and evidence-package delivery.

CPD-accredited credential

A portable professional certification recognized by sponsors, CROs, payers, and health systems across North America, EMEA, and Asia-Pacific.

Global curriculum, emerging-markets depth

In addition to US and EU data sources and frameworks, the program covers the GCC, Africa, Southeast Asia, Latin America, and India in detail.

Aligned with 2025–2026 industry standards

Anchored to FDA RWE Demonstration Projects, EMA DARWIN EU integration, ICH M14 (2025), and ICH E9(R1) — target trial emulation, the estimand framework, synthetic control arms, AI-enabled methods, and pharmacoepidemiology.

Empty space, drag to resize

— Who this is for

Who this certification is for

The program is designed for clinical, regulatory, data, and health-economics professionals moving into or expanding within Real-World Evidence. It is suited to:

  • CRAs, CRCs, and study managers transitioning from interventional trials into RWE study design and oversight.

  • Biostatisticians, data analysts, epidemiologists, and informaticians specializing in observational and real-world methods.
  • Pharmacists, physicians, and life-science graduates seeking globally portable careers in evidence generation.
  • HEOR, market access, and outcomes research professionals responsible for evidence supporting reimbursement and patient access.
  • Pharmacovigilance and safety professionals expanding into active surveillance, signal detection, and life-cycle safety.
  • Medical affairs, real-world insights, and scientific communications leads who need fluency in RWE methodology and terminology.
  • Public health, ministry of health, and health-system professionals applying RWE to policy, planning, and patient-care decisions.
  • Academic, hospital, and consulting researchers preparing for industry RWE roles in sponsors, biotechs, and CROs.
  • Professionals building local RWE capability and competing for regional and global roles.

— What’s included

A rigorous, end-to-end RWE/RWD curriculum

Career-ready outcomes

Graduates leave able to write a pre-specified RWE protocol, defend a study design, build a regulatory- or HTA-ready evidence package, and contribute to RWE programs from day one. The capstone portfolio is structured specifically to demonstrate hiring-relevant capability to sponsors, CROs, biotechs, payers, and health systems.

Current industry methodology

The curriculum covers the methods sponsors and regulators expect in 2026 — target trial emulation, the estimand framework, synthetic and external control arms, causal inference and machine learning, NLP and large language models on EHR data, OMOP common data model, and federated analytics. The program is updated continuously to reflect evolving industry and regulatory expectations.

Global curriculum with emerging-markets depth

In addition to North American and European data sources and frameworks, the program covers the GCC, Africa, Southeast Asia, Latin America, Japan, Korea, and India in detail — the regions where RWE capability is being built today and where qualified professionals are most in demand. Learners are positioned to compete for both regional and global roles.

Designed for working professionals

Self-paced and fully online, with 12 months of platform access. No prior RWE experience is required. Learners complete the program with a CPD-accredited credential, a full portfolio of artifacts (protocol, statistical analysis plan, access-and-outcomes evidence package), and a recorded capstone defense suitable to share with hiring managers and sponsors.

— A look inside the program

How the RWE/RWD certification is taught

Short walkthroughs of how faculty teach modern Real-World Evidence — fit-for-purpose data selection, target trial emulation, the estimand framework, and the evidence packages sponsors, payers, and regulators expect in 2026. Self-paced, fully online, taught with a global lens.
Inside the RWE classroom
Live methodology walkthroughs

Course Curriculum

— Program outcomes

What you graduate with

The certification is designed to leave learners with a defensible body of work — not only a credential. Upon successful completion, graduates hold:

A complete pre-specified RWE study protocol authored by the learner and defended in the capstone — applicable to registry-based, observational, and hybrid study designs.
A statistical analysis plan prepared to a standard suitable for biostatistician peer review.
An access-and-outcomes evidence package translating study findings into HTA, payer, and patient-access narratives.
Working fluency in the major RWE frameworks and methodologies, including data sources, populations, and regulatory expectations across the US, EU, GCC, Africa, Southeast Asia, Latin America, and Asia-Pacific.
A CPD-accredited Professional Certification suitable for LinkedIn, CV, and sponsor or employer profiles.

A recorded capstone defense demonstrating applied capability to hiring managers, sponsors, and reviewers.

Twelve months of platform access for ongoing reference, refresh, and continuing professional development.

A professional positioning as a Real-World Evidence practitioner ready to contribute to sponsor, CRO, payer, or health-system RWE programs.

Bundle offer