eDeviation the New Protocol Deviations Cloud Software Solution
"In a context of increasingly complex clinical trials, we are proud to offer a solution that will help sponsors, CROs and EC/IRB minimize the risks associated with protocol deviations.
- "In a context of increasingly complex clinical trials, we are proud to offer a solution that will help sponsors, CROs and EC/IRB minimize the risks associated with protocol deviations.
- "\nA protocol deviation is any change, divergence, or departure from the study design or procedures defined in the approved protocol, consent document, recruitment process, or study materials (e.g.
- "Protocol deviation" is a general term encompassing protocol exceptions, changes made to avoid immediateharm to subjects, and protocol violations.
- Protocol deviations can be either major or minor according to the impact of the deviation on patientsafety and data integrity.\neDeviation is aProtocol Deviations and Violations management cloud software designed to collect, manageand reviewprotocol deviations in a simple, effective, and GxP-compliant way.\n'