Press Releases

AMC Health Quality Management System for Telehealth in Clinical Trials Use Compliant with 21 CFR 820 and 21 CFR 11 Requirements(2)

May 27, 2015, 00:00 AM by Michael Croft
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 Health’s 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 company’s efforts to validate its telehealth platform for the Clinical Trials marketplace,” said Michael O’Brien, 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 we’ve 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.

Tweet This: .@AMCHealth telehealth QMS ready to validate clinical trials platform #telehealth #21CFR11 #CFR820 | http://bit.ly/1Ewx438 #clinicaltrials

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