Why should you choose an MHRA-accredited clinical unit?

What is a MHRA Phase I accreditation?
If you are considering placing your phase I study in the UK, you may have come across CROs or Phase I Units with an MHRA Phase I accreditation – but what does this mean?

The MHRA’s voluntary phase I accreditation scheme is available to organisations conducting phase I trials but is particularly for organisations conducting first in human (FIH) trials1.

The scheme is designed to support organisations with a framework to ensure trials are not only safe and regulated, but that surpass the basic requirements for good clinical practice to ensure the UK is a first-class choice for the highest standards for participant safety and high -quality clinical trials.

The highest safety standards for phase I centres of excellence
Accredited organisations must have additional procedures in place to ensure study participants are safe, which is the highest priority for early phase trials. The MHRA accreditation is issued to organisations that “encompassed the highest standards for avoiding harm to trial subjects and for handling medical emergencies”2 which serves to reassure sponsors that the organisation conducting their study is a well-equipped for a safe, well managed clinical trial.

A review of procedure, facilities, training and experience.
To gain an MHRA accreditation, organisations are subject to in-depth reviews which assess procedures and facilities of the unit, in addition to the training and experience of employees. This ensures that not only does an MHRA accredited unit have the tools and processes in place for a safe, well-managed trial, the unit is also equipped with experienced and knowledgeable teams who are capable of delivering a phase I study to the MHRA’s standards.

A mark of trust for regulators and sponsors
According to the MHRA’s documentation on requirements for MHRA accreditation, ‘the original aim of the MHRA Phase I Accreditation Scheme was to increase the scope and depth of inspections in order to provide the MHRA and Research Ethics Committees (REC) with more information about the units seeking to conduct these trials, so that approval decisions could be made even more robust.’3

Phase I units in the UK are not required to have the MHRA accreditation to conduct phase I studies, however the absence of an MHRA accreditation will be considered, and additional inspections of the trial site may be required for regulatory approval – which can add unforeseen delays.

By selecting an UK MHRA Phase I accredited Unit to conduct early phase healthy volunteer and patient trials, sponsors can be assured that they are working with a Unit and team that “make significant contributions to enhancing the safety of volunteers and are considered to be centres of excellence for Phase I research”2.

Always inspection ready
To achieve an MHRA accreditation organisations are required to apply and must then pass an inspection. However, once gained, organisations are required to be inspected every 3 years to maintain their accredited status. Placing a clinical trial with an MHRA accredited unit ensures your CRO is running high-quality, safe clinical trials with inspection-ready processes.

Simbec-Orion are proud to be part of the MHRA’s phase I accreditation scheme, having No Critical and No Major findings in our most recent (May 2024) inspection.

Contact us to find out more about our phase I experience.

1 https://www.gov.uk/guidance/mhra-phase-i-accreditation-scheme

2 https://assets.publishing.service.gov.uk/media/631612de8fa8f502256a956e/1._MHRA_Phase_I_Accreditation_Scheme_Requirements_v4.1_12_August_2022.pdf

3 https://assets.publishing.service.gov.uk/media/631612de8fa8f502256a956e/1._MHRA_Phase_I_Accreditation_Scheme_Requirements_v4.1_12_August_2022.pdf  Page 3

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