OUR SERVICES

Quality Assurance Auditing

quality-assurance

At Mudra Clinical Research Organization (CRO), we prioritize quality in every aspect of our operations. Our documented Quality System includes effective Standard Operating Procedures (SOPs) and comprehensive staff training to ensure compliance with GCP and regulatory requirements.

Our experienced Quality Assurance (QA) team ensures the implementation of appropriate quality systems, safeguards the rights and safety of subjects, and maintains the validity and integrity of clinical studies.

The Mudra Quality Management Group offers support in managing quality management systems by reviewing structures, policies, and processes, establishing efficient systems, and identifying opportunities for continuous improvement through corrective and preventative actions.

Our auditing services cover various aspects, including investigator sites, clinical laboratories, vendors, and compliance with regulatory requirements. These audits provide a snapshot of the trial’s quality, ensuring high-quality data submission that meets global standards.

Key auditing services at Mudra CRO:

  • Pre-Regulatory Inspection GCP Audits/Inspection Readiness
  • Clinical Investigator Site Audits
  • Database Audit
  • Clinical study report Audit
  • System/Process Audit
  • Protocol and consent forms review
  • GMP/Investigational Product Storage, Distribution & Manufacturing Audit
  • GLP/Central or Local Laboratories Audit
  • Vendor & Service Provider Audits/Assessments
  • IRB Audits
  • Trial Master File Audits
  • Validation/21 CFR Part 11 Compliance Audits
  • Standard Operating Procedure (SOP) Evaluations

At Mudra CRO, our commitment to quality assurance ensures that your clinical studies are conducted with the highest standards, meeting regulatory requirements and protecting the rights and safety of all subjects involved.