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Martin O'Kane

Increasing the efficiency of your clinical trial authorisation (CTA) application and reducing the need for subsequent substantial amendments

Posted by: and , Posted on: - Categories: Behind the Scenes, Clinical Trials

In this blog we describe ways to facilitate the review of your initial application, how to avoid unnecessary amendments and, where substantial amendments are necessary, how to submit these so that the review is as efficient as possible, leading to …

The past, the present, and the future of clinical trials transparency in the UK

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The UK has been leading the way in supporting and promoting transparency of clinical trials. Following our exit from the EU, the MHRA has been monitoring compliance with registration of trials of medicines in World Health Organisation recognised public databases, …

One Hundred Clinical Trial Applications Authorised under the Combined Ways of Working (CWoW) pilot

Posted by: , Posted on: - Categories: Improving Our Services
Image of Martin O’Kane, MHRA, and Catherine Blewett, HRA

Last year we updated you on a pilot program to streamline the way clinical trials applications were reviewed in the UK. Working closely with colleagues in the Health Research Authority (HRA) and across the Devolved Administrations we jointly developed a …