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Session 6 Track A: E-solutions: eSource, e-Trial Master File, Cloud Solutions, e-Health
Session Chair(s)
Valdo Arnera, DrMed, MD
Medical Advisor
Clario, Switzerland
Multiple new ‘e’ technology tools and IT systems are available to enable the collection of higher volume and higher quality of data, available for data quality trending analysis at the time of data collection. The use of electronic tools and systems should allow us to improve patient safety and to collect more relevant and accurate clinical data. As a consequence, new strategies to risk based approaches to computerized system validation could be implemented, based on the facts that technology should be understood as the risk mitigator rather than as a risk for clinical data quality and integrity.
Speaker(s)
Setting the Scene
Valdo Arnera, DrMed, MD
Clario, Switzerland
Medical Advisor
The PhUSE Framework for Cloud Adoption in the Regulated Life Sciences Industry
Tony Hewer, PHD
Cepheus Consultancy Limited, United Kingdom
Founder & Director
Deconstructing the Clinical Trial Process End-to-End and Developing Disruptive Solutions that Leverage Leading-Edge Technologies, Digital Health (Mobile Health, Wearable Devices & Sensors) and Novel Settings
Bryan McDowell, MBA, MSC
Clario, Switzerland
Vice President, eCOA Clinical Science and Consulting
eSolutions and the Need for Convergence to Support Clinical Operations
Isabelle de Zegher, DrMed, MD, MS, MSC
b!loba, Belgium
Founder