ICH GCP E6(R3) is about to go live in the EU

The countdown is on – ICH GCP E6(R3) is about to go live in the EU, and everyone’s getting prepared!

As a service provider (you caught that new R3 definition during training, right?), Flex Databases is here to support you through the transition. Let’s highlight a few areas that are especially important for our clients:

✅3.6.8 The sponsor should have access to relevant information (e.g., SOPs and performance metrics) for selection and oversight of service providers.
We’re always audit-ready. From SOPs and organizational charts to system documentation – everything you need for a smooth, effortless vendor assessment is at your fingertips.

✅3.6.9 The sponsor should ensure appropriate oversight of important trial-related activities that are transferred to service providers, including activities further subcontracted by the service provider.
We’ve got you covered with uptime reports, backup logs, and testing records – transparent and traceable metrics to support robust oversight, no surprises.

✅3.9.5 The range and extent of oversight measures should be fit for purpose and tailored to the complexity of and risks associated with the trial. The selection and oversight of investigators and service providers are fundamental features of the oversight process. Oversight by the sponsor includes quality assurance and quality control processes relating to the trial-related activities of investigators and service providers.

Let’s simplify this together. A Quality Agreement helps capture all expectations clearly – so you stay in control without wasting time or resources.

Have questions or want to start your oversight planning? We’re just a message away. 👉 contact@flexdatabases.com