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Clinical Site Monitoring

Our Clinical Research Associates (CRAs) are highly trained professionals who exercise ultimate efficiency in managing investigator sites. Lead CRAs are the primary point of contact between the CRAs and Project Manager (PM).

BCS develops Sponsor-approved monitoring plan for each study

Our Clinical Research Associates (CRAs) are highly trained professionals who exercise ultimate efficiency in managing investigator sites. Lead CRAs are the primary point of contact between the CRAs and Project Manager (PM).

Clinical Site Monitoring Services include

  • Investigator Interest Questionnaire/Site Assessment Visit
  • Pre-Site Selection Visit
  • Investigator Meeting Planning and Presentation
  • Study Initiation Visit
  • Interim Monitoring Visit
  • Serious Adverse Events
  • Regulatory Document Preparation and Collection.
  • Identification and Reporting of Protocol Deviations/Violations
  • Corrective and Preventive Actions
  • Close Out
  • Site Termination
  • Specialized Lab Audits
  • Clinical Study Material Accountability

First monitoring visit will be scheduled based on the risk profile of the study. Subsequent monitoring visits will then take place as outlined in the Clinical Monitoring Plan.