RBM | TRI The RBQM Experts

Risk Management Exercise 3 - Shared Narrative & Understanding

If different departments have differing understandings or perceptions of a risk it can spell disaster. This exercise aligns them.

Risk Management Exercise 2 - Risk Reviews

If this risk occurs, there will be a morning after. On that morning after, what will we wish we’d done? All part of the Risk Review exercise

Risk Management Exercise 1 - Critical Assumptions Review

How to run a Critical Assumptions Review exercise to set your clinical trial up for success & create the open culture promoted in ICH E8(R1)

Name names to successfully implement RBQM

Over 50% of organizations we surveyed didn't have a named person responsible for RBQM implementation.

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

RBM/RBQM take-up before the pandemic was slow. It's picking up, but there's still a long way to go.

Why not look at the positive side?

When it comes to Risk-Based Quality Management (RBQM) and Centralized Monitoring people often bring up the idea of comparing sites to...

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

Macarena Sahores discusses why Change is the greatest challenge facing the sector

From RBQM sceptic to convert

Hi! My name is Svetlana and I’m self-confessed RBQM convert. It wasn’t always that way. When I first started out in my career as a...

The Quality Continuum

Duncan Hall discusses the new concept of a "Quality Continuum" in relation to ICH E6(R3), and what it means in practice for your trials.