UK Clinical Trial Regulations: What Smaller Biotech and Pharma Companies Need to Know
The UK clinical trial landscape changed materially on 28 April 2026, when the amended Clinical Trials Regulations took full effect. The
Uncategorized
What ICH GCP E6 (R3) Means for Sponsor Oversight
ICH E6(R3) is not just a refresh of familiar GCP language. It is a clearer statement of what modern sponsor
Preparing for an MHRA Inspection
An MHRA inspection should never feel like a last-minute scramble. In reality, inspection readiness is built well before the inspection
How to conduct a meaningful GCP qualification audit of a service provider
A qualification audit should do more than confirm that a Service Providers exists, has SOPs and holds a certificate on
Why service provider oversight is more than a tick box exercise
Service Provider oversight is often described as if it were a single task: qualify the provider, file the paperwork, schedule
5 common gaps sponsors miss when outsourcing clinical trial activities
Outsourcing can bring valuable expertise, flexibility and speed. It can also create blind spots if sponsor oversight is not designed