Elevating Clinical Trials: Why Service Provider Life Cycle Management Deserves More Focus Under ICH E6(R3)

RQA Blog Post

In today’s world of clinical trials, working with third-party service providers—like contract research organisations (CROs) and tech vendors—is just part of the job. But with ICH E6(R3) shaking things up, it’s clear that proper vendor oversight needs to be more than just ticking boxes. Here’s why focusing on service provider life cycle management is crucial and how you can keep things on track to ensure quality and compliance.

What’s Changed with ICH E6(R3)?

The new guidance makes it crystal clear: sponsors must have risk-based oversight throughout the entire engagement with service providers—from picking the right ones to closing out projects. Why the big focus? Because as trials get more complex (think remote monitoring, decentralised trials, and new tech), poor vendor management could put data integrity, compliance, and patient safety at risk.

Let’s dive into the key areas you need to master to stay ahead.

1. Picking the Right Providers: It’s All About Risk

When choosing a service provider, it’s tempting to focus on cost or speed. But under ICH E6(R3), you need a risk-based approach to selection. This means digging into:

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