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 placed to offer a full range of early phase FIH/exploratory development studies including Proof of Concept/Translational Medicine studies. This accreditation augments our collaboration with the Tayside Academic Health Sciences Centre including the Clinical Research Centre for Proof of Concept studies.”