Kirsty Wydenbach

Deputy Unit Manager/Senior Medical Assessor, CTU

Regulators’ experience of clinical trials during the Covid-19 pandemic (Part 3) – looking forward

Gail Francis, Martin O'Kane, Kirsty Wydenbach and Lisa Campbell, 18 February 2022 - Good clinical practice, Inside the Inspectorate

In parts one and two of this series, we looked at how we responded to the unprecedented challenges the COVID-19 pandemic and the lessons we have learned. In this final part, we explore the challenges ahead. Remote access to EHRs …

Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned

Gail Francis, Martin O'Kane, Kirsty Wydenbach and Lisa Campbell, 14 February 2022 - Good clinical practice, Inside the Inspectorate

In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the set-up and approval of clinical trials. Now we look at the unprecedented challenges we faced in …

Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 1) – our initial response

Gail Francis, Martin O'Kane, Kirsty Wydenbach and Lisa Campbell, 8 February 2022 - Good clinical practice, Inside the Inspectorate

The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and how we move forward to implement those learnings for the benefit of the UK …

Advice for Management of Clinical trials in relation to Coronavirus

Gail Francis and Kirsty Wydenbach, 12 March 2020 - Compliance matters, Good clinical practice

MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.

How to manage safety reporting in a blinded trial

Gail Francis and Kirsty Wydenbach, 9 April 2019 - Compliance matters, Good clinical practice

Guidance on the unblinding and reporting of serious adverse reactions (SARs) associated with comparator drugs

Is it really a First in Human trial? Categorising and assessing the risks correctly

Jennifer Martin and Kirsty Wydenbach, 20 December 2018 - Compliance matters, Good clinical practice

All early phase clinical trials have risks associated with them that require mitigation. Following not just the legislation but also all the associated guidance will help in maintaining public safety and the credibility of data.

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