Chiltern Achieves Supplementary Accreditation From the Medicines and Healthcare Products Regulatory Agency
By Chiltern, PRNESunday, June 6, 2010
LONDON, June 7, 2010 - Chiltern International Limited (Chiltern), a global contract research
organization (CRO), has announced that Chiltern Early Phase Limited, based in
Ninewells Hospital and Medical School in Dundee, Scotland, has achieved
Supplementary Accreditation from the Medicines and Healthcare products
Regulatory Agency (MHRA).
Dr Brian Sanderson, Medical Director, Chiltern Early Phase, explains, "In
November 2007, the MHRA launched a voluntary accreditation scheme for units
conducting Phase 1 studies in the UK. The scheme is designed to provide
assurance to sponsors and participants that the accredited units meet
satisfactory standards of quality and safety with adherence to Good Clinical
Practice as well as best medical practice for subject safety."
There are two tiers of accreditation:
- Standard Accreditation - units accredited to this level will be accredited to carry out all Phase 1 trials except those First in Human (FIH) trials requiring Clinical Trial Expert Advisory Group of the Commission of Human Medicines (CTEAG) review. - Supplementary Accreditation - units accredited to this level will be accredited to carry out all Phase 1 trials including those First in Human (FIH) trials requiring CTEAG review.
Glenn Kerkhof, Chiltern CEO, stated, "With the achievement of
Supplementary Accreditation, Chiltern Early Phase is uniquely placed to offer
a full range of early phase FIH/exploratory development studies including
Proof of Concept/Translational Medicine studies performed to the highest
standards of safety and quality. This accreditation augments our
collaboration with the Tayside Academic Health Sciences Centre including the
Clinical Research Centre for Proof of Concept studies."
Company profile
About Chiltern:
Established in 1982, Chiltern is a leading global Contract Research
Organization with extensive experience conducting and staffing international
Phase I to Phase IV clinical trials across a broad range of therapeutic areas
for a wide variety of clients. Chiltern has conducted trials in more than 40
countries, has 24 offices and legal entities within 21 countries, resources
in 37 countries and employs nearly 1,400 people globally. Chiltern provides
Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and
Regulatory Affairs and Resourcing Solutions services. Further information:
www.chiltern.com.
Contact: Natalie Chong Susan Ojanen Marketing Director Marketing Associate Chiltern International Ltd., UK Chiltern International Inc., USA Tel: +44-(0)-1753-512-000 Tel: +1-(423)-968-9533 natalie.chong@chiltern.com susan.ojanen@chiltern.com
Natalie Chong, Marketing Director, Chiltern International Ltd., UK, +44-(0)-1753-512-000, natalie.chong at chiltern.com; or Susan Ojanen, Marketing Associate, Chiltern International Inc., USA, +1-423-968 9533, susan.ojanen at chiltern.com
Tags: Chiltern, June 7, London, United Kingdom