Accreditations

Accreditations

Richmond Pharmacology is the first Early Phase CRO to receive MHRA Standard and Supplementary Accreditations for two hospital based clinical trial centres.

The scheme gives assurance that units within the scheme meet satisfactory standards for avoiding harm to trial subjects and for handling medical emergencies should they arise.
The scheme has a classification system based on facilities, training and experience of personnel and ability to manage trials with certain risk factors that would require review by the Clinical Trials Expert Advisory Group of the Commission on Human Medicines, (CTEAG).

Classification of Units

There are two types of accreditation.

Standard Accreditation

This is the minimum standard applied for all UK Phase I Units.
Standard units are accredited to carry out all phase I trials other than First In Human (FIH) trials with risk factors that would require CTEAG review. Examples of trials where expert advice may be sought can be found on the MHRA website.

Supplementary Accreditation

All accredited units that are able to carry out clinical trials with compounds at all levels of risk, including those that require review of risk factors by CTEAG, require Supplementary Accreditation.

The unit must demonstrate that appropriately trained and experienced staff are available on dosing days. It is not a requirement that these units are physically located within a hospital, providing that the unit is able to demonstrate that experienced personnel and facilities are immediately available to manage medical emergencies. Nevertheless, both of Richmond Pharmacology's accredited trial units are located within hospitals.

Following the provision of accreditation by the MHRA, an accreditation certificate is issued. The certificate is valid for 2 years, and a re-inspection will be performed prior to renewal of the certificate.