Kirsty Wydenbach

Deputy Unit Manager/Senior Medical Assessor, CTU

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

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

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

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

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

Posted by: , , and , Posted on: - Categories: Good clinical practice, Inside the Inspectorate
Illustration Of A Team Of Scientists Working On Coronavirus Vaccine In The Laboratory

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 …

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

Posted by: and , Posted on: - Categories: Compliance matters, Good clinical practice
an arrangement of scrabble tiles spelling out the word 'ASSESS'

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.