My RBQM predictions for 2022

A great Sponsor question

RBQM magic, mystery, and reality

Why people really buy RBQM

Name names to successfully implement RBQM

What will Clinical Trials look like in 5 years’ time?

FDA - Real World Data draft guidance and RBQM

RBM/RBQM take up is slow according to ACRO, but it’s improving

ICH E6(R3) – Are people asking the wrong questions already?

Why not look at the positive side?

Grouping Investigative Sites into Risk Groups for “Fit for Purpose” Monitoring

Data can switch on lightbulbs

It’s all or nothing with ICH E6(R2) Quality Management

I agree with the ICH E6(R3) EWC - Change is the greatest challenge

From RBQM sceptic to convert

Early phase trials need risk-based quality management too

Reflections on a year at TRI

The Quality Continuum

Why 100% SDV is not the way forward

RBQM and Sites: Engage. Don’t beat