“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.”
Kinnelon, NJ (PRWEB) March 18, 2010
ClinAudits, LLC, an independent, 3rd party provider of GXP compliance, clinical trial auditing, and quality remediation solutions for the pharmaceutical, medical device, biotechnology, and tissue engineering industries, announced today that it has joined the Bioanalytical Quality Standard Initiative (BQSI) Expert Working Group, to contribute to the Group’s objective of establishing specific regulations and documented quality management standards for laboratory analytical functions supporting clinical trials.
During the last two years, a pharmaceutical industry consortium has been working to develop an industry acceptable guideline applicable to standardizing acceptable laboratory and quality management practices for bioanalytical studies supporting clinical trials. As a specialized provider of GXP compliance services, with established expertise in Good Clinical Practices (GCP) auditing, ClinAudits has joined representatives from a number of top worldwide pharmaceutical and generic companies in support of this initiative. 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.”
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 the productivity of their clients. For example, ClinAudits provides Clinical Trial Supply audits, but does not conduct or manage clinical trials, further justifying its objectivity and independence. ClinAudits performs multiple types of audits in GCP, both domestically and internationally including but not limited to investigator sites, CRO (pre-qualification or post capability), IRB, final study reports, central labs, phase 1 units, computer validation, mock FDA/EMEA, pharmacovigilance and database audits. For more information about the pharmaceutical auditing services and quality remediation solutions provided by ClinAudits, visit http://www.clinaudits.com/about.htm.
Companies interested in becoming BQSI Expert Working Group members can contact Dr. Kirk Smith by email at ksmith(at)synomicspharma(dot)com, or by calling Synomics Pharma at 508-273-0450. Interested parties may also join the BioAnalytical Quality Standard Initiative (BQSI) Group on LinkedIn. A white paper, titled “BioAnalytical Quality Standard Initiative — Implementing ICH Q10 for Clinical Trials”, describes the BQSI Expert Working Group’s objectives in further detail. To download the white paper and a copy of the guidance document, visit http://info.synomicspharma.com/bqsi/.
Press Contact: Cheri Wilczek, (973) 492-8108