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ClinAudits Joins Bioanalytical Quality Standards Initiative (BQSI) Expert Working Group
Date:3/18/2010

nitiative. The BQSI guidance document has been posted to http://www.regulations.gov, and the public has been invited to add comments to the docket file, number FDA-2009-D-0428.

"A robust quality standard addressing the bioanalytical testing of clinical trial samples is needed to ensure consistency in the way industry and, specifically, contract organizations, conduct this work,” said Dr. Kirk Smith, Synomics Pharma’s Senior Director of Regulatory Affairs & Quality Systems, and chairman of the BQSI. “ClinAudits’ experience in auditing for compliance with FDA regulations, International Congress on Harmonization (ICH) Guidelines, and local governmental regulatory guidelines will be highly beneficial to the BQSI Expert Working Group.”

“As a provider of objective compliance audits and quality remediation solutions, ClinAudits is aware of the inconsistencies in the conduct of bioanalysis in support of current clinical trials, and recognizes that existing guidelines do not address laboratory analysis associated with such trials,” stated Cheri Wilczek, President of ClinAudits. “The Bioanalytical Quality Standard Initiative guidance document addresses those inconsistencies. The implementation of this standard can help to improve the quality and safety of pharmaceutical products.”

About ClinAudits
Since 1994, ClinAudits has been in the business of conducting domestic and international Good Clinical Practice (GCP) regulatory compliance and auditing services to the pharmaceutical, medical device, biotechnology, biologics industries, and to major academic institutions. ClinAudits is a niche provider specifically targeting GCP auditing, GCP training, and SOP design, to increase t
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