NEW YORK, NY, UNITED STATES - May 27, 2015 - AMC Health, a leading provider of real-time patient management solutions, has announced that it has successfully undergone a third-party review of its Quality Management System to meet the requirements of 21 CFR 820 and 21 CFR 11 for its next generation telehealth platform, which will be one of the first of its kind for clinical trials
NEW YORK, NY, UNITED STATES - May 27, 2015 - AMC Health, a leading provider
of real-time patient management solutions, has announced that it
has successfully undergone a third-party review of its Quality
Management System to meet the requirements of 21 CFR 820 and 21 CFR
11 for its next generation telehealth platform, which will be one
of the first of its kind for clinical trials.
An independent firm specializing in the integration of quality
assurance/regulatory compliance and business operations in the Life
Sciences market conducted the review and assessed that AMC Healths
Quality Management System processes support the standards for
safety, privacy, data integrity and security. No critical findings
were noted after a desktop review, staff interviews and an on-site
review of records.
This marks an important achievement in the companys efforts to
validate its telehealth platform for the Clinical Trials
marketplace, said Michael OBrien, President, Clinical Trials
Division, AMC Health.
AMC Health has been performing groundbreaking work in remote
patient monitoring and engagement since its founding in 2002.
Launching its Clinical Trials division in 2013, the company
continues to leverage its expertise in telehealth across the
healthcare continuum to advance innovation in clinical trials.
The Clinical Trials solution will allow study subjects to
participate in video visits from home, which enables research sites
to collect biometric and subjective data, remotely. This will allow
patients who live far from a traditional clinical trial site to
participate via virtual visits in place of, or as a complement to,
face-to-face site visits. Among its many benefits, virtual
visits can expand the geographic recruitment area by reducing the
travel and time burden on patients.
We continue to use the insights weve gained over 12 years to
leverage how telehealth is being applied in current clinical trials
and the potential it holds for future innovations, said Nesim
Bildirici, Founder and CEO of AMC Health.
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telehealth QMS ready to validate clinical trials platform
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About AMC Health
As a leading provider of customized, scalable, cost-effective
real-time patient management solutions, the company assists
organizations serving at-risk populations and those conducting
clinical trials. Its patient engagement, health monitoring and care
coordination solutions have been proven in several peer-reviewed,
published journals to improve patient outcomes, improve quality of
care and reduce overall healthcare costs. AMC Health is
headquartered in New York City. For more information, visit
www.amchealth.com.
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Press Contact:
Joy DiNaro, Amendola Communications for AMC Health
Phone: 847.809.0406
Email: jdinaro@acmarketingpr.com