New regulations for clinical trials – Join our Route B substantial modifications pilot

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September 2025: This blog provides information about the Route B substantial modifications and why you should sign up to take part in the pilot if you are eligible. We developed new clinical trial legislation in collaboration with the Health Research …

Decentralised Manufacturing: emerging considerations

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Decentralised Manufacturing (DM) is the overarching term used in the UK to cover the two elements of the new manufacturing and supply framework: point of care (POC) and modular manufacturing (MM). A cross-agency team of Quality and Clinical Trial assessors, …