Quality Control (QC) & Quality Assurance (QA)

At First E Clinical, we know that quality is the foundation of every successful clinical trial. Our QC and QA services are designed to help research sites maintain the highest standards of data accuracy, regulatory compliance, and operational efficiency throughout the study lifecycle.

• Data Verification & Accuracy Checks
  Cross-checking EDC entries against source documents to ensure precise and error-free data capture.
• Protocol Compliance Audits
  Conducting regular audits to confirm adherence to study protocols, SOPs, and regulatory guidelines.
• Regulatory Compliance Assessments
  Supporting sites in meeting FDA, ICH-GCP, and global regulatory requirements with confidence.
• Site Process Optimization
  Identifying inefficiencies and recommending process improvements to boost accuracy and performance.
• Pre-Audit & Inspection Readiness
  Performing mock audits and preparing teams for inspections by regulatory authorities.
   

Strong QC and QA practices safeguard data integrity, reduce the risk of compliance issues, and lead to more reliable trial outcomes. Our team partners closely with sites to ensure audit-readiness, minimize risks, and deliver excellence at every step.