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: mhra/aboutus/index.htm.
For further information on ClinPhone's clinical trial technology
solutions, please visit clinphone, or alternatively email
infoclinphone.
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.
clinphone