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 […]
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