Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution

By ePharmaSolutions
Published: September 2017

The volume of safety reports being sent to investigative sites is frustrating for investigators, sometimes causing them to disregard letters which may result in clinically-significant safety signals being missed in the noise of non-significant event reports, and the workload volume may even lead sites to consider ending their participation in the clinical trial. How can we ensure that investigative sites only receive the reports they truly need to review? This question must be answered in order to bring efficiency back to the review process and to ensure that investigators are spending their time where it matters most, with the study participants.

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ePharmaSolutions (ePS) is a leading provider of e-clinical solutions that improve the way that clinical trial sites are selected, trained, activated, and managed. By applying fresh thinking to old problems, we deliver clever, technology-enabled solutions that empower sponsors, contract research organizations and investigator sites to “un-complicate” the chaos of clinical trial management.