Monitoring

• Fully Dedicated ICH-GCP trained clinical research associates experienced in working with Contract Research Organizations and Pharmaceutical companies ensures that the clinical sites monitored is credible.
• Focused in, on site coordination and monitoring of Phase I, II, III, and IV clinical trials.
• Site Quality Assurance
• Monitoring of Site documents
• Review of
  • Informed Consent Forms (ICF)
  • Patient source document
  • CRFs
  • Study logs
  • Compliance with required guideline and protocols
  • Investigator Site File
  • Progress and status reports