Quality is the core of every Novum study. Novum Quality Assurance is independent of operational units and reports directly to the CEO. Quality Assurance is responsible for maintaining the integrity of Novum’s scientific processes and overall business operations.
Quality Assurance teams conduct a combination of audit plans, visits and reports for all Early Phase studies and Clinical Trials. These experienced specialists audit all aspects of a study, from study activities through collected data and the final report.
Within our Early Phase Clinics, QA audits are conducted on all clinical studies intended for regulatory submission. Minimally, these include a QA audit of specific aspects of the study (e.g., dosing, blood sample collection and processing) to ensure compliance with the study protocol and Novum SOPs. Within Clinical Trials, QA audits both our internal processes and the clinical sites that are conducting the study. These audits ensure that the sites are ready for possible FDA inspections and that all of Novum's monitoring and study management SOPs are followed. In addition to a 100% quality control program on all data collected, the final reports are evaluated utilizing our comprehensive QA program to ensure completeness and accuracy. Audit reports are generated and submitted for management review to ensure continuous quality improvement.
By adhering to the highest quality assurance standards in our internal processes, at each Novum clinical site and throughout our network of investigator sites, we ensure the regulatory readiness of all studies.