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Session 6 Continued: Track A: Inspections and E-Solutions: Case Studies on Regional Differences
Session Chair(s)
Bryan McDowell, MBA, MSc
Vice President, eCOA Clinical Science and Consulting
Clario, Switzerland
Today, we need to understand IT systems and e-technology as clinical development process enablers. Relative to the legacy paper processes, technology reduces and mitigates risks, provided we understand how we setup and properly validate an e-technology-enabled clinical trial. In order to use the full potential of the currently available technology, the pharmaceutical industry, the regulatory authorities and the service providers need align to continuously improve the compliance and quality standards. The paper process as a quality reference appears to become an outdated quality concept, but major regulatory authorities nevertheless have a different understanding on how data quality and data integrity should be achieved in today’s clinical trial environment.
Speaker(s)
Regional Differences between Europe and USA
Beat Widler, PhD
Widler & Schiemann AG, Switzerland
Co-Founder and Vice President, ACRES; Managing Director
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