I was pleased to hear the news that my previous employer, Guy’s and St Thomas’ NHS Foundation Trust, finally achieved MHRA Phase I accreditation for the NIHR Guy’s Clinical Research Facility.
I initiated this project in December 2013, when I was working as the R&D / NIHR Biomedical Research Centre Quality Assurance Manager. It took almost four years of careful planning and implementation to achieve this incredible milestone. After undertaking a Good Clinical Practice gap analysis, I identified that we needed to develop our quality system considerably in order to be phase I accreditation compliant. In addition, we needed to invest in infrastructure. We had to redesign some of the facility and we also needed to increase staffing levels. This was all to ensure that we had the correct resources needed to be compliant with phase I accreditation guidelines.
In May 2016, we were ready to submit our application to the MHRA. After six months, we received notification that we’d have our first inspection. This was a challenging project but it also felt incredibly motivating for our team to work through these challenges together. It was identified that additional work was required, and after an extra drive in early 2017, we were reinspected in May. I completed the final corrective action preventative action plan over the summer of 2017 and we submitted the final document package to the MHRA in August.
The project was a success due to the fact that we approached it as a team. Everyone involved, from all levels of the organisation, and also our partners at Kings College London, contributed to this amazing outcome. I am proud to have led this project and I’m pleased that we achieved the outcome we worked so hard towards.
I left my role at the end of August to commence my own clinical research consultancy. If you’re interested in undertaking similar work: whether it be a GCP/Phase I gap analysis to see where you are, or a more general quality system review, please get in contact at email@example.com.
Paul Cross is a clinical research consultant, specialising in quality assurance, risk management, pharmacovigilance and early phase clinical trial management.