ClinPhone Completes Medicines And Healthcare Products Regulatory Agency (MHRA) Inspection

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Article Date: 03 Jun 2008 - 1:00 PDT

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ClinPhone, the world's largest Clinical Technology Organization (CTO), has received the GCP Inspection Statement to complete the latest Inspection by the GCP Inspectorate of the Medicines and Healthcare Products Regulatory Agency (MHRA).

The MHRA is an executive agency of the 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 organization 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 their 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 23rd April 2008.

Steve Kent, CEO, ClinPhone comments, "This reinforces to our clients that ClinPhone are 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."

To find out more about the Medicines and Healthcare Products Regulatory Agency (MHRA), please visit: http://www.mhra.gov.uk/aboutus/index.htm.

For further information on ClinPhone's clinical trial technology solutions, please visit http://www.clinphone.com, or alternatively email info@clinphone.com.

About ClinPhone

ClinPhone plc is the world's largest Clinical Technology Organization (CTO) with an unrivaled track record of innovation in the development of clinical trial technology. Headquartered in Nottingham UK with offices around the world, ClinPhone works with leading global biotechnology organizations, pharmaceutical companies and Contract Research Organizations (CROs).

ClinPhone is the largest and most accomplished CTO with experience in over 2,000 clinical trials spanning 88 countries and 71 languages. The Company's experience includes Phase I to Phase IV studies, ranging from single center studies with 20 patients to "mega trials" with over 40,000 patients.

ClinPhone's product portfolio, consisting of software and services, is backed by continuous research and investment in the latest technologies, coupled with extensive in-depth clinical industry experience. Its industry-leading software solutions include electronic data capture (EDC) and clinical trial management systems (CTMS), which can be licensed or implemented as hosted solutions. Delivered via its renowned Interactive Voice Response (IVR) and Interactive Web Response (IWR) platform, ClinPhone offers randomization, trial supply management, trial supply simulation, electronic patient reported outcomes (ePRO), and patient recruitment solutions.

ClinPhone's products can integrate, taking the pain out of juggling and managing multiple sources of disparate information. This approach provides more control over data, improves data integrity and streamlines the data validation process.

http://www.clinphone.com