Clinical Research | TRI The RBQM Experts

EMA Implements E8(R1)

EMA formally implements ICH E8(R1). That's good for RBQM and the 'quality continuum' with E6(R3).

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

Why do I need RBQM technology?

The one word answer is "Complexity". The longer answer includes DCTs, new technology, multiple data sources and new quality risks.

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...

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.

Why 100% SDV is not the way forward

As a recent university graduate starting a career in clinical trials, there's lots I've had to learn. While getting to grips with the...