HITLAB Completes GCP Audit for FDA Smart Device & App Compliance

Expands HITLAB's Clinical Trials Capabilities for Smart Biomedical Applications and Devices

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Healthcare Innovation and Technology Lab

Dec 15, 2014, 05:02 ET

NEW YORK, Dec. 15, 2014 /PRNewswire-USNewswire/ -- HITLAB^SM announced today its completion of a Good Clinical Practices (GCP) audit to confirm its adherence to current U.S. Food and Drug Administration (FDA) regulations. This accomplishment enables HITLAB to conduct regulated smart device and smart phone application trials utilizing the highest principles for patient safety and research quality.

"HITLAB is determined to improve global healthcare access, quality, and delivery with innovative technology," said Laura Pugliese, HITLAB's innovation research manager. "Now, we can add biomedical devices and applications to our already robust list of research capabilities. We're thrilled by the possibilities inherent in this expansion, and gratified by our team's dedication to quality."

Pugliese added, "Even in this fast-paced industry—as devices evolve at breakneck speed—HITLAB has deep evaluation and validation expertise needed to maintain efficient, effective, and FDA-compliant clinical trials using smart devices and smart phone applications."

Smart Consulting Group (http://smartconsultinggrp.com/), an industry consultant SME on FDA regulatory compliance issues, conducted HITLAB's GCP audit. The group thoroughly reviewed HITLAB's quality management system process and IT infrastructure to ensure the company's adherence to current FDA quality standards.

HITLAB added FDA-compliant clinical trials for smart devices and apps in order to broaden its services for clients and accelerate innovative, quality healthcare options for people across the globe.

About HITLAB
HITLAB is a healthcare innovation and teaching lab with a presence in the United States and India. We ideate, create, and evaluate innovative solutions to healthcare challenges for companies, foundations, multi-lateral agencies, and governments. In partnership with others whose missions align with ours, we independently, ethically, and efficiently design studies, programs, and products that improve healthcare access and quality throughout the world. www.hitlab.org

Contact:
HITLAB
212-543-0100
[email protected]
FACEBOOK: http://www.facebook.com/hitlab.org
TWITTER: @HITLABNYC

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SOURCE Healthcare Innovation and Technology Lab