BOSTON & GENEVA--(EON: Enhanced Online News)--PHT Corporation has appointed clinical research industry veteran and regulatory compliance expert Michael Owings as Vice President, Quality and Regulatory compliance. PHT is the leading provider of technologies used to collect Patient-Driven eData for clinical research.
“I joined PHT because I believe in the mission of the company to improve human health and quality of life through the increased adoption of patient-driven eData Systems in research. I look forward to accelerating growth by expanding the quality management and compliance function.”
Michael is an expert in clinical informatics applied to pharmaceutical research. He has 20+ years of experience implementing and maintaining privacy, quality and security frameworks to ensure compliance with global regulations. He is a veteran of inspections by FDA, EMA and the PMDA related to EDC, Good Clinical Practice, and validation of computer systems. Prior to joining PHT Michael was with Phase Forward/Oracle Health Sciences for 12+ years as Vice President, Audit and Compliance responsible for 30+ life science and healthcare products, services and cloud offerings including Oracle Clinical and Phase Forward’s InForm EDC application.
PHT President and CEO Philip Lee said, “It is a pleasure to welcome Michael to the PHT Senior Leadership Team. His experience and track record of success in the clinical trials technology market, combined with his in-depth knowledge of the global regulatory environment, will help PHT deliver greater value to trial sponsors.”
Michael is a Certified Information Privacy Professional (CIPP) with expertise in all aspects of quality management and regulatory compliance. Prior to his tenure at Phase Forward/Oracle, Michael worked in pharmaceutical research and quality compliance.
At PHT, Michael will lead the team responsible for the quality and regulatory compliance of PHT Systems where his extensive experience will complement PHT’s focus on eSource and electronic clinical outcome assessments (COA).
Michael said, “I joined PHT because I believe in the mission of the company to improve human health and quality of life through the increased adoption of patient-driven eData Systems in research. I look forward to accelerating growth by expanding the quality management and compliance function.”
About PHT Corporation
PHT Corporation helps pharmaceutical companies and CROs conduct clinical trial programs with greater confidence, ease and accuracy. Proven PHT electronic clinical outcome assessment (eCOA) Systems collect patient-driven eData via smartphones, tablets and the web. This data, available via StudyWorks™ online reporting portal, provides sponsors and clinicians with a real time window into how patients feel and function. PHT has helped trial sponsors collect patient-driven eData in 650+ global trials resulting in 16+ regulatory approvals. PHT offers the regulatory, technological, and scientific expertise today’s market demands and patients deserve. Visit www.phtcorp.com for more information on PHT. Follow PHT on LinkedIn, Twitter, Google+ and YouTube.