Mar 16, 2015, 00:00
by
Michael Croft
PRINCETON, NJ - Mar 16, 2015 - WIRB-Copernicus Group (WCG),
the world's largest provider of regulatory and ethical review
services and software to support clinical research, announced today
that its Western Institutional Review Board® (WIRB®) company has
been certified to ISO 9001:2008 by BSI, confirming that it
operates an excellent quality management system
Designation recognizes high standards met
by WIRB's quality management system
PRINCETON, NJ - Mar 16, 2015 - WIRB-Copernicus Group (WCG), the
worlds largest provider of regulatory and ethical review services
and software to support clinical research, announced today that its
Western Institutional Review Board® (WIRB®) company has been
certified to ISO 9001:2008 by BSI, confirming that it
operates an excellent quality management system.
WIRB and its sister IRB, Copernicus Group, are the only two
IRBs to have met ISO quality management standards and to have
received ISO 9001:2008 certification, commented WCG Chairman and
CEO Donald A. Deieso, Ph.D. We are proud to have set a new high
bar for quality management in ethical review.
At WCG, we are always looking for ways to increase efficiencies
within the clinical research process while - most importantly -
maintaining the highest standards of human subject protection,
added WCG Chief Compliance Officer David Forster, JD, MA, CIP.
Achieving ISO certification is a powerful indicator of our
commitment to continuous improvement in all aspects of our
operations.
Todd VanderVen, president of BSI Americas, stated, WIRB is to
be congratulated for its achievement of certification to ISO
9001:2008. Given Copernicus Group IRBs earlier certification,
WIRBs achievement sends a clear message of WCGs commitment to
quality and dedication to continual improvement.
All ISO 9000 standards are based on a series of quality
management principles. They require company leaders to establish
clear goals and objectives for their quality management system and
endeavor to get all their employees involved. Participating
companies adopt a strong customer focus with employees aiming not
just to meet customer expectations but to exceed them. They also
take both a process- and systems-based management approach, and
strive for continual improvement in their companys overall
performance, using internal audits to track progress.
ISO 9001:2008 is implemented by more than one million companies
and organizations in more than 170 countries, according to ISO.
About BSI
One Company, One Solution. By packaging assessment, training and
a management system toolset, BSI delivers a business improvement
solution that combines it all in a comprehensive service offering
and allows us to provide an integrated approach to meet the needs
of the organization and embed excellence across the business. BSI
presents a one-stop value proposition from the decision to improve
systems through to registration and continual improvement. From
start to finish, BSI helps turn complexity into simplicity. To
learn more, please visit www.bsigroup.com.
About ISO
ISO is the worlds largest developer and publisher of
International Standards. ISO is a network of national standards
bodies of 166 countries, with a Central Secretariat in Geneva,
Switzerland. For more information, please visit http://www.iso.org/iso/home.html.
About WIRB-Copernicus Group
WIRB-Copernicus Group (WCG) is the world's largest provider of
regulatory and ethical solutions for clinical research. The company
provides Institutional Review Board (IRB) and Institutional
Biosafety Committee (IBC) reviews, and Human Research Protection
(HRP), Good Clinical Practice (GCP) and Biosafety consulting
services. Its technology offerings include IRB workflow management
solutions (IRBNet), clinical trial management software for sponsors
and contract research organizations (ePharmaSolutions), and Part-11
compliant online learning solutions for research professionals (WCG
Academy).
The pioneer of independent ethical oversight, WCG continues to
drive progress in the clinical research space. WCG empowers clients
to accelerate life-saving advancements, while ensuring that the
risks of progress never outweigh the value of human life.
For more information, please visit www.wcgclinical.com or follow
us on Twitter @WCGClinical.