Navigation Links
BSI and ACRES Developing Global Accreditation Standards for Clinical Research Sites
Date:1/12/2016

London-based British Standards Institution (BSI), a leader in promoting excellence through standards development for business processes globally, and Massachusetts-based Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector collaborative building a global system for clinical research, today announced a major strategic partnership to promote excellence and improve quality and efficiency in medical product development worldwide. BSI joins ACRES ongoing Site Accreditation and Standards Initiative (SASI) with the intention to develop and implement standards of excellence for clinical research sites and engage with all parties of the clinical research endeavor to develop an innovative process for “dynamic accreditation” of research sites that will promote, recognize and reward excellence.

BSI and ACRES also announced their intention to create professional stakeholder groups to oversee and maintain the standards, and to operate the global accreditation process.

Formed in 1901 as the world’s first national standards body and providing services to more than 70,000 sites in 150 countries across a range of industry sectors, BSI brings deep experience in standards development and accreditation processes to ACRES efforts. BSI and ACRES will work with stakeholders from across the clinical research endeavor in developing both the standards and the system for independent third-party accreditation.

Gary Slack, SVP for Global Healthcare at BSI, announced the new partnership, noting “BSI believes excellence must be a habit, that excellence and responsibility must be embedded in sustainable business practices, and by doing so, improved quality and effectiveness are not just achieved, they are inevitable. We share these beliefs with ACRES and are excited to be part of these long-overdue efforts.”

SASI, building on its previous efforts in surveying and consulting on current site quality criteria, is constructing a comprehensive set of standards covering essential domains of patient and subject engagement and protection, site personnel, research integrity, facilities, information systems and data management, management and administration as well as quality management. These standards and derived metrics will enable an innovative ‘dynamic accreditation’ process that automatically monitors operational data in real time to continuously improve site and system performance, benefitting stakeholders while minimizing research site burdens.

“High-performing quality research sites are critical elements in a safe, effective system for testing new medical products and doing clinical research to develop new therapies. For too long we have failed to recognize and reward truly excellent, professional sites and lacked a system for doing so. No more--this is true transformational change, a new way of doing things, and the expertise that BSI brings to ACRES global collaboration brings the future much closer than anyone could have imagined”, said ACRES president and co-founder, Dr. Greg Koski.

Arti Bajpai, co-chair of ACRES Global Standards Working Party developing the standards, commented “ACRES will not itself create nor hold the standards—as an enterprise-wide effort, everyone—sites, sponsors, CROs, ethics review committees, patients, providers and regulators—has a stake in the standards. Like the accreditation process itself, they too must be dynamic.” Bajpai, president of Pennsylvania-based Compliance and Quality Integration (CQI) Consulting, and co-chair Dr. Amir Kalali, Head of the Neuroscience Center of Excellence at Quintiles and co-founder of CNS Summit, are currently assembling domain-specific standards teams to coordinate and evaluate the new standards, targeted for public comment and evaluation in 2016.

ACRES
The Alliance for Clinical Research and Excellence (ACRES) is a non-profit leveraging the expertise of stakeholders worldwide to collaboratively build a shared global system for clinical trials that are responsibly conducted according to the highest standards of safety, quality and efficiency, based in principles of Accountable Research™. Adapting lessons from industries successfully implementing principles of systems and safety engineering, this system will employ integrated information technologies as well as interoperable standards, policies and practices to enhance clinical research safety, quality and efficiency worldwide. For more information, please contact Dr. Mary Tobin at mtobin(at)acresglobal(dot)net.

BSI
The world’s first standards organization, BSI now delivers a comprehensive business services portfolio to clients, helping them raise their performance and enhance their competitiveness worldwide, currently publishing over 2,500 standards annually and originating many of the world’s most commonly management systems standards, including work on clinical research safety and quality standards for medical devices]. BSI’s values of integrity, continual improvement and inclusivity ensure BSI operates in a socially responsible way. For more information, please contact the BSI press office pressoffice(at)bsigroup(dot)com or +44 20 8996 6330.

Read the full story at http://www.prweb.com/releases/GregKoskiACRES/GarySlackBSI/prweb13155354.htm.


'/>"/>
Source: PRWeb
Copyright©2016 Vocus, Inc.
All rights reserved


Related biology technology :

1. ACRES Launches Global Clinical Research Network Technology Platform
2. ACRES Announces Strategic Alliance with Atlantis Global Research Institute
3. ACRES and PharmaTrain Announce Strategic Alliance
4. Clinical Research Site-Expert Johan Karlberg to Lead ACRES Global Network Development
5. ACRES Names Katherine Madigan VP for Global Alliances and Advocacy
6. BRANY and ACRES to Recognize Excellence at Clinical Trial Sites in Strategic Alliance
7. Astra Nova and ACRES Partner on Quality and Access of Training for Research Professionals
8. Fujitsu and ACRES Ally to Enhance Safety and Accelerate Medicines Development
9. IACRN and ACRES to Support Clinical Research Nurses
10. ACRES Opens First Clinical Research Affiliate Organization in Japan
11. Clinverse Inc. and ACRES Announce Strategic Partnership
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/9/2017)... ... ... At its national board meeting in North Carolina, ARCS® Foundation ... Physics and Astronomy, has been selected for membership in ARCS Alumni Hall of ... Breakthrough Prize in Fundamental physics for the discovery of the accelerating expansion of the ...
(Date:10/9/2017)... ... October 09, 2017 , ... ... medical journal, Epilepsia, Brain Sentinel’s SPEAC® System which uses the surface electromyography ... generalized tonic-clonic seizures (GTCS) using surface electromyography (sEMG). The prospective multicenter phase ...
(Date:10/7/2017)... ... October 06, 2017 , ... Phase ... metagenome deconvolution product, featuring the first commercially available Hi-C kit. Researchers can ... Hi-C metagenome deconvolution using their own facilities, supplementing the company’s full-service ProxiMeta ...
(Date:10/6/2017)... ... October 06, 2017 , ... ... healthcare and technology sector at their fourth annual Conference where founders, investors, innovative ... speakers and the ELEVATE pitch competition showcasing early stage digital health and med ...
Breaking Biology Technology:
(Date:4/13/2017)... , April 13, 2017 UBM,s Advanced ... will feature emerging and evolving technology through ... Innovation Summits will run alongside the expo portion of ... sessions, panels and demonstrations focused on trending topics within ... advanced design and manufacturing event will take place June ...
(Date:4/11/2017)... , April 11, 2017 NXT-ID, Inc. ... technology company, announces the appointment of independent Directors Mr. ... to its Board of Directors, furthering the company,s corporate governance ... Gino ... we look forward to their guidance and benefiting from their ...
(Date:4/4/2017)... --  EyeLock LLC , a leader of iris-based identity ... and Trademark Office (USPTO) has issued U.S. Patent No. ... iris image with a face image acquired in sequence ... th issued patent. "The issuance ... multi-modal biometric capabilities that have recently come to market ...
Breaking Biology News(10 mins):