PHT Corporation Completes Audit of Quality Management System by TUV Rheinland of North America and Discusses Quality in Clinical Trials
Global ePRO market leader's exclusive ISO certification ensures market's highest quality processes and products; PHT educates community about ensuring quality clinical trials
BOSTON, Mass - August 31, 2010 - PHT Corporation announced that its ISO certification received an upgrade to ISO9001:2008 following the successful completion of an audit of its Quality Management System by TUV Rheinland of North America. PHT is the global innovator in ePRO (electronic patient reported outcome) and PRO (patient reported outcome) solutions that maximize clinical data management by incorporating the world's best digital diaries in eClinical trials. PHT is the only handheld eDiary provider to achieve and maintain ISO certification of its quality management system.
PHT initially achieved ISO 9001:2000 certification in 2002 after being audited by TUV Rheinland of North America, and has since undergone annual surveillance audits. PHT was recertified in December of 2005 and 2008; PHT achieved certification to the updated ISO9001:2008 standard in 2009.
In reviewing PHT's Quality Management System, Dr. William West, Senior Lead Auditor at TUV Rheinland of North America, said, "In particular I was quite impressed with PHT's stellar handheld device logistics and shipping function including the setup, the processes in place, and the people who are implementing the production processes. Additionally, the internal audits across the organization I reviewed were notable for their thoroughness and clarity."
PHT President and CEO Phil Lee said, "Sponsors rely on PHT's ePRO solutions to capture and manage critical endpoint data. PHT's investment in ISO certification gives sponsors the added confidence that our systems are reliable, our solutions perform as designed, and our team is focused on customer satisfaction and continuous business improvement."
The many tangible benefits of PHT's ISO certification for sponsors:
- Confidence that data collected with the PHT ePRO System will withstand global regulatory scrutiny and review due to superior quality systems management;
- Faster ePRO trial timelines and reduced costs across trials due to consistent ePRO delivery methodology;
- Responsive and dedicated ePRO service from well-trained and educated staff that focuses entirely on delivering and supporting the PHT ePRO System
PHT Executive Who Led ISO Process to Speak at Prestigious ExL Pharma Conference
This fall Rod Thorell, PHT's Director of Quality Management and Compliance and a key leader in PHT's ISO recertification process, will speak about the critical role of quality for clinical trials vendors. Mr. Thorell will speak on Thursday, 14 October at 8:15 am at ExL Pharma's "Quality Oversight of Clinical Vendors" conference about the respective roles pharmaceutical sponsors and vendors have to ensure successful clinical trials. Conference leaders selected Mr. Thorell to speak based on his track record of quality management excellence and vision in his work expanding the role and visibility of the Quality System at PHT. The conference takes place at the Westin Arlington Gateway Hotel in Arlington, Virginia.
About PHT Corporation
PHT is the global market leader and innovator in ePRO (electronic patient reported outcome) and PRO (patient reported outcome) solutions that maximize clinical data management by incorporating the world's best digital diaries in eClinical trials. More than 100 biopharmaceutical companies use PHT's electronic diaries to collect reliable clinical trial data. PHT's proven LogPad® and versatile SitePad® Tablet Systems deliver the voice of the patient, in 88 languages, from homes and sites in 65 countries around the world. Patient experiences captured firsthand by PHT's ePRO System have been used successfully in at least 14 regulatory submissions and 11 approvals to date. For more information on PRO and ePRO innovations, review the interactive content and demonstrations at the award-winning www.phtcorp.com.
Contact: Brenda Nashawaty, [email protected], 617-688-3253