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How eSource Solutions are Impacting Clinical Research Sites, Patients, Regulators and Drug and Device Companies
Session Chair(s)
Jules Mitchel, PhD, MBA
President and CEO
THI Pharma Services, United States
In the not too distant future, we as an industry will execute, manage and monitor clinical trials the same way we execute, manage and monitor banking transactions online, quickly and without the need to maintain paper records. However, as we bring new and innovative technology solutions to the market, we must assess and address the concerns of all of the stakeholders within the clinical trial enterprise. We need to assure patients, clinical research sites, pharmaceutical and device companies, as well as regulators, that there will be improved efficiencies, improved data quality and integrity, improved patient safety, reduced fraud and an overall better experience during the clinical trial process. Topics to be addressed include clinical site acceptance, regulatory concerns, software validation, risk assessments, change management within companies, and a comprehensive assessments of the risks and rewards.
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