Quotient Clinical receives Phase 1 trials qualification from MHRA
Quotient Clinical, a division of UK drug development services provider Quotient Bioresearch, has been awarded Supplementary Accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA).
Quotient Clinical, a division of UK drug development services provider Quotient Bioresearch, has been awarded Supplementary Accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA). This is one of the highest levels of accreditation in Europe and confirms that Quotient Clinical is qualified to perform the full range of Phase I trials, including First-in-Human (FIH) studies for low molecular weight chemical entities and biologics.
The MHRA voluntary accreditation scheme was introduced in April 2008 in line with recommendations from the MHRA clinical trial expert advisory group, to maximise subject safety, and provides formal guidance on the standards expected in a clinical unit conducting FIH studies.
Quotient Clinical was formed in May 2009 following the acquisitions of two companies, Charles River Laboratories" Edinburgh clinical research facility in May 2009 (formerly Inveresk Clinical Research) and Pharmaceutical Profiles in December 2008.
The company, which employs 160 people, specialises in early clinical drug development and offers a streamlined process to reduce the time from First-in-Man studies through to proof of concept, integrating flexible drug product manufacture into clinical trials.
Mark Egerton, managing director of Quotient Clinical, said: "Our MHRA Supplementary Accreditation provides volunteers and sponsors with additional reassurance of the high standards we apply in performing clinical studies. This award acknowledges our continued commitment to quality and safety and underpins our status as one of the leading clinical units in Europe."
