Clinical Trial Monitoring

With an average of 25 years of experience, KPE Research’s monitors are second to none. They have experience in Phase I-IV trials in a wide array of inpatient and outpatient clinical trial settings. We have monitors throughout the United States. All of our monitors adhere to the same high standards that are our trademark. Monitoring includes:

  • Qualifying, initiating, monitoring, and closing clinical trial sites to assure adherence to protocol, SOPs, and GCP/ICH and other applicable regulations.
  • Conducting source document review and verify accuracy of collected study data.
  • Assessing regulatory compliance and essential document maintenance at clinical trial sites.
  • Maintaining investigational product accountability.
  • Documenting accurate and timely Sponsor/site communications and site visit reports.
  • Liaising with Data Management to assure complete and accurate resolution of queries, and to review data listings.
  • Assuring site reporting of serious/unexpected adverse events.

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