PDMS is a comprehensive Protocol Deviation Management System designed to capture, assess, and resolve protocol deviations across late-phase clinical trials. By providing structured workflows for deviation classification, root cause analysis, and CAPA management, PDMS enables trial teams to maintain regulatory compliance, reduce operational risk, and protect the integrity of study protocols and clinical data.
Identifies protocol deviations early to enable faster corrective action and prevent escalation.
Reduces compliance risk and potential regulatory findings through controlled deviation management.
Ensures uniform deviation assessment and resolution across studies and sites using standardised workflows.
Provides real-time visibility into deviations and trends to support proactive quality management.
Drives continuous improvement by linking deviations to actionable CAPA insights.
Maintains complete, traceable, and inspection-ready deviation documentation.
reduction in recurring protocol deviations
faster deviation review and closure cycles
improvement in CAPA effectiveness across studies
traceability of audit trails for all deviation activities
