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

Released on: June 2, 2008, 6:15 am

Press Release Author: The Scott Partnership

Industry:

Press Release Summary: ClinPhone Completes Medicines and Healthcare Products
Regulatory Agency
(MHRA) Inspection

Press Release Body: Contact Information:
Charlotte Culley/Fiona Robinson
The Scott Partnership
Phone: +44 (0) 1477 539539
E-mail: clinphone@scottpr.com

Kathleen Pomykola
ClinPhone plc
Phone : +1 609 524 4242
Email: kpomykol@clinphone.com

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

(Nottingham UK, 2 June 2008). 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: www.mhra.gov.uk/aboutus/index.htm.

For further information on ClinPhone\'s clinical trial technology solutions, please
visit 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.

For further press information contact: Fiona Robinson, The Scott Partnership, 1
Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom Tel: + 44
1477 539539. Fax: +44 1477 539540 E:clinphone@scottpr.com


Web Site: http://

Contact Details: Charlotte Culley/Fiona Robinson
The Scott Partnership
Phone: +44 (0) 1477 539539
E-mail: clinphone@scottpr.com

Kathleen Pomykola
ClinPhone plc
Phone : +1 609 524 4242
Email: kpomykol@clinphone.com

  • Printer Friendly Format
  • Back to previous page...
  • Back to home page...
  • Submit your press releases...
  •