Regulatory Compliance and Quality Assurance
"Expert Compliance for Clinical Research Success."
Maintaining regulatory compliance and ensuring quality assurance are paramount in clinical site management. These aspects not
only protect patient safety but also uphold the integrity of the research and its results. Effective site management involves a thorough
understanding of both local and international regulations, including Good Clinical Practice (GCP) guidelines, ICH requirements, and
specific country regulations.
Quality assurance processes should be embedded throughout the trial lifecycle, from site selection to study close-out. This includes
regular audits, meticulous documentation practices, and continuous staff training on regulatory updates and compliance procedures.
- Key Regulatory Bodies in Clinical Research
- Essential Quality Assurance Measures
- Documentation Best Practices