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Chiltern International Limited (Chiltern) 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:
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.”