Clinical Monitoring

Palm Beach CRO offers extensive clinical monitoring services from qualification and initiation to site closeout. All monitoring activities are conducted in accordance with the study protocol, Standard Operating Procedures (SOPs), ICH, GCP and applicable FDA Regulations. Our regional Clinical Monitors are skilled, qualified, knowledgeable professionals with extensive clinical research experience across a wide variety of therapeutic areas.

Clinical Monitoring Services include:

  • Site Selection, Qualification and Initiation
  • Regulatory Document Collection and Management
  • Development of Study Specific Procedures, Manuals and Tools
  • Conducting Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs) and Closeout Visits (COVs)
  • Finalizing Monitoring Visit Reports within 15 Business Days
  • Ongoing Site Monitoring and Management
  • Remote Monitoring
  • Adverse Event (AE) and Serious Adverse Events (SAEs) Review
  • Monitoring of Site Recruitment and Enrollment Activity
  • Subject Recruitment and Retention Support
  • Protocol Deviations/Violations Tracking
  • Reporting of Site Fraud and/or Misconduct
  • Conducting Ongoing Training of Site Personnel
  • Source Document Verification and CRF Review
  • Query Management and Resolution Support
  • Review of Investigator Regulatory Files and Trial Master File (TMF) for Completeness
  • Clinical and Non-Clinical Supply Management
  • Discuss Site Responsibilities and Requirements for Successful Study Conduct