ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that its hospital-based Clinical Pharmacology Unit in Manchester, UK has achieved Supplementary Accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA).The purpose built unit, part of the ICON Development Solutions division, is situated on the largest academic healthcare campus in Europe.
Supplementary Accreditation is the highest level of accreditation in Europe - going beyond Standard Accreditation to demonstrate that ICON’s Clinical Pharmacology Unit adheres to the highest clinical safety standards. This designation permits ICON to carry out all Phase I trials including First in Human (FIH) trials requiring review from the EAG (Expert Advisory Group).
Thomas Frey, President ICON Development Solutions, commented: “Our Clinical Pharmacology team in Manchester worked closely with the MHRA during their routine inspection to demonstrate our active commitment to safety and quality. This accreditation award, combined with our experience conducting over 1,500 early phase studies, reinforces to trial volunteers and sponsors alike that ICON is an industry-leader in Phase I clinical research. We are pleased to have participated in this voluntary accreditation process that ensures continuous safety improvements are realised in early clinical development.”
The MHRA established this accreditation scheme in 2006 to formalise routine, rigorous inspections so that clinical safety standards are made even more robust. Accreditation is granted following a successful MHRA GCP Inspection where a unit must demonstrate appropriately trained personnel and facilities are immediately available to manage medical emergencies.
