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mHealth / mClinical and Clinical Trials: A Candid Discussion on Opportunities and Risks
Session Chair(s)
Philip Coran
Principal, Global Compliance and Strategy, Medidata Solutions, United States
This session will focus on the proliferation of mobile health (mHealth) and mClinical devices in the consumer and medical market and how these services may enhance clinical trials. The panel will cover perspectives from a variety of stakeholders including the FDA.
Learning Objective : Discuss the differences between mHealth and mClinical and clinical trial data; Identify how clinical trials can be enhanced by involving mHealth/mClinical data; Describe how to mitigate the risks to data integrity and subject privacy by using mHealth/mClinical services.
Speaker(s)
mClinical/mHealth: Opportunities and Risks
Craig Lipset, MPH
Co-Chair, Digital Trials and Research Alliance, United States
mClinical/mHealth: Regulatory Insights on Risks and Opportunities
Phillip D. Kronstein, MD
Team Leader, Division of Clinical Compliance Evaluation, OSI, CDER , FDA, United States
mClinical/mHealth: Regulatory Insights on Risks and Opportunities
Julian M. Jenkins
Group Vice President, Development Operations and Project Management, Incyte Corporation, United States
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