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Combined review to facilitate speedier set up for clinical research trials

Combined review to facilitate speedier set up for clinical research trials
July 23, 2021 SueCarr

From January 2022, all new Clinical Trials of Investigational Medicinal Products (CTIMPs) in the UK will be subject to a combined review from the MHRA and the UK Research Ethics Services, in collaboration with the Health Research Authority (HRA), facilitating rapid start-up and benefitting patients sooner.

Applicants need only make a single application for both Clinical Trial Authorisation and Research Ethics Committee (REC) opinion and approval is delivered together. A number of sponsors have already used this new process with some reporting a 30 percent improvement in overall trial setup times.

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