Protocol adherence, process consistency and data integrity are essential for the success of any clinical study today. However, with multi-arm, multi-location studies, and multiple stakeholders managing data, ensuring such process consistency and quality is a challenge for pharma companies, CROs, hospitals and trial managers.
QMatra’s rigorous analysis of trial procedures and data are designed to meet the highest compliance standards. We help you identify potential risks and verify the quality of data before submitting it for regulatory approvals.
Our auditing support includes:
- Investigator sites. Evaluate trial sites for protocol and regulatory compliance, and adherence to ethical practices and patient safety criteria.
- Trial master file. Review essential documents that collectively demonstrate compliance with GCP and regulatory requirements.
- Pharmacovigilance. Assess processes and reports essential for meeting pharmacovigilance norms.
- Data management. Check clarity, consistency and quality of trial data. Build robust processes to collect and analyse the information. Generate credible reports that pass regulatory scrutiny.
- Computer system validation. Verify processes and documents that show compliance with 21 CFR Part 11.
- Vendor qualification. Double-check the facilities, tools and procedures followed by vendors. Use the information to identify and diffuse potential risks.
- Process audit. Determine consistency of organisational processes across studies, project teams, time frames and locations.
- For cause. Assess suspicions related to data collection and quality. Weed out stray incidents; take informed decisions about its usability.
- Good Manufacturing Practices. Protect the safety and efficacy of your clinical products during manufacture. Ensure production in a GCP-GMP compliant environment.