RESEARCH

eDeviation the Latest Protocol Deviations Cloud Software Solution

eDeviation | April 21, 2021

Ethical GmbH, a Swiss organization that provides personalized software solutions for clinical research committee management, has created a new software solution to help with protocol deviation (PD) evaluation and management.

The new eDeviation® solution will allow clinical trial sponsors, CROs, and EC/IRBs to handle all protocol deviations in a single repository, assess them electronically in a blinded or unblinded manner, and track all operations.

Protocol deviations (PD) are a recognized problem for clinical trials because they can jeopardize subjects' safety, rights, and welfare, as well as the study's data integrity, and thereby violate Good Clinical Practice standards. PDs must be established and submitted to the Institutional Review Board of clinical trials (IRB). They may also be classified as major or minor based on the effect on patient care and data integrity. Finally, corrective measures must be taken to ensure that the PDs do not reoccur, and all decisions and actions must be reported for GxP compliance.

Clinical research teams face a significant administrative burden when it comes to managing and assessing PDs. In this context, a software platform that can support and document both PD assessment and management activities will significantly simplify the work of clinical research teams.

"With eDeviation®, Ethical's portfolio of clinical research software solutions continues to expand to help our customers run their trials more efficiently and effectively," says Mimmo Garibbo, Director of Ethical GmbH. "In an era of increasingly complex clinical trials, we are pleased to have a solution that will assist sponsors, CROs, and EC/IRBs in minimizing the risk associated with protocol deviations."

About Protocol Deviations
A protocol deviation is any change, divergence, or departure from the approved protocol, consent agreement, recruitment process, or study materials (e.g., questionnaires) originally approved by the EC/IRB. The expression "protocol deviation" refers to protocol exceptions, modifications made to avoid immediate damage to subjects, and protocol violations. Protocol deviations may be classified as major or minor based on their effect on patient safety and data integrity.

About eDeviation
eDeviation® is a Protocol Deviations and Violations management cloud software designed to collect, manage and review protocol deviations in a simple, effective, and GxP-compliant way.

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