Case Study: Company X achieves independent QA oversight and a streamlined quality system with Montrium

Company X - Customer Case Study

Company X, an international clinical data management Clinical Research Organisation, engaged Montrium after an internal review revealed excessive custom system builds, poor documentation versioning and traceability, a manual and validation-heavy study setup process, and insufficient independent Quality Assurance oversight. Company X contracted Montrium for Quality Assurance consulting services, including independent QA oversight of incidents, deviations, CAPAs, quality system documentation and regulatory compliance.

Montrium worked remotely as Company X’s Quality group, reviewing and approving core and study-specific documentation, consolidating SOPs, establishing SOP review schedules, organizing self-inspections, reviewing CAPAs and supporting audit preparation. As a result, Montrium helped Company X gain greater control of its quality system, close the QA oversight gap, allow operational teams to focus on their core tasks, and begin streamlining the quality system to reduce granularity and improve efficiency.

Company X