ClinPhone completes MHRA inspection
World's largest CTO has received the GCP Inspection Statement to complete the latest Inspection by the GCP Inspectorate of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
The MHRA is an executive agency of the UK Department of Health and was established in April 2003 from a merger between the Medicines Control Agency and the Medical Devices Agency.
The agency is responsible for ensuring that medicines and medical devices work and are acceptably safe.
As with any organisation involved in the clinical trials process, ClinPhone has implemented rigorous procedures to ensure compliance with good clinical practice (GCP).
These are assessed by clients, who conduct in excess of 40 audits per year at ClinPhone, as well as by regulatory authorities.
In the UK, ClinPhone is subject to inspection by the MHRA, in accordance with the Medicines for Human Use (Clinical Trials) Regulations (Statutory Instruments 2004/1031 as amended).
ClinPhone underwent its second routine GCP Inspection in mid-November 2007.
Following submission of responses to the inspection report, a revised GCP Inspection Statement, signifying the completion of the latest inspection cycle, was received on 23 April 2008.
Steve Kent, CEO, ClinPhone comments: "This reinforces to our clients that ClinPhone is fully committed to good clinical practice.
"We have the appropriate policies and procedures in place, as well as robust technology with sufficient back-up systems, to successfully manage our clients' studies to the very highest standards."
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