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

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.

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.”

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 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 www.clinaudits.com/about.htm.

About BQSI
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

###

Read the full story at http://www.prweb.com/releases/2010/03/prweb3742234.htm.


'/>"/>
Source: PRWeb
Copyright©2010 Vocus, Inc.
All rights reserved  

Related medicine news :

1. Dr. Young-Ho Oh Joins Harrington Physician Services; Orthopedic Surgeon Will Enhance Hospitals Surgery Capabilities
2. Netball Australia Joins Forces with DealsDirect.com.au, Australia's Leading Online Department Store
3. Peyton Marshall Joins LeveragePoint Innovations Board
4. Walter Chesley Joins Blue Cross Board of Trustees
5. North American Spine Joins Governor Arnold Schwarzenegger at 2010 ICA Symposium
6. Suunto Joins ANT+ Interoperable Ecosystem
7. Alan Henry, M.D. Joins MedSolutions as Chief Medical Officer of Premerus
8. Barcode Joins the Battle of the Bulge in New iPhone App
9. DNC Chairman Kaine Joins President Obama in Calling on Congress to Finish the Job, Pass Health Insurance Reform
10. National Hispanic Council on Aging Joins the Administration in Mission to Combat Medicare Fraud By Empowering Hispanics
11. George Lundberg, MD, Joins MedPage Today(R) as Editor-at-Large
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
ClinAudits Joins Bioanalytical Quality Standards Initiative (BQSI) Expert Working Group 
(Date:6/25/2016)... Montreal, Canada (PRWEB) , ... June 25, 2016 , ... ... the pursuit of success. In terms of the latter, setting the bar too high ... low, risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was out of ... verbally and physically. , “When something upset him, he couldn’t control his emotions,” remembers Marcy. ... throw rocks at my other children and say he was going to kill them. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Haute ... Dr. Barry M. Weintraub as a prominent plastic surgeon and the network’s newest ... world, and the most handsome men, look naturally attractive. Plastic surgery should be ...
(Date:6/24/2016)... ... ... Venture Construction Group (VCG) sponsors Luke’s Wings 5th ... Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The event raised ... have been wounded in battle and their families. Venture Construction Group is a 2016 ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Any dentist who has made an implant supported ... Many of them do not even offer this as a ... laboratory costs involved. And those who ARE able to offer ... high cost that the majority of today,s patients would not ... Zadeh , founder of Dental Evolutions Inc. and inventor of ...
(Date:6/23/2016)... , June 23, 2016  In a startling report released today, ... their residents by lacking a comprehensive, proven plan to eliminate prescription ... definitive ranking of how states are tackling the worst drug crisis ... four states – Kentucky , New ... Vermont . Of the 28 failing states, three – ...
(Date:6/23/2016)... Research and Markets has announced the ... 2016 - Forecast to 2022" report to their offering. ... up to date financial data derived from varied research sources ... with potential impact on the market during the next five ... comprises of sub markets, regional and country level analysis. The ...
Breaking Medicine Technology: