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Vendor Management/CRO Supervision > Project Management > Medical Writing > Clinical Trial Monitoring >  
Clinical Trial Monitoring

  • Monitoring and site management from site selection, trial initiation, ethics committee application, through recruitment to site close-out.
  • Experience of monitoring trials in phases I to III in multiple therapeutic areas including oncology, CNS, dermatology and HIV for drug and device studies.
  • Preparation of investigator sites for audit and inspection.  In the past I have been interviewed as site CRA for sponsor GCP inspections by both the MHRA and the FDA.
  • I am a highly experienced and efficient monitor.  I aim for audit-readiness at all times, build good rapport with site teams and achieve low query rates.
  • High-quality monitoring is crucial to the success of a clinical trial.  Each monitoring report is an essential document.  It must be accurate, complete and submitted to the sponsor as soon as possible after the visit.   Whether writing or reviewing them, I make it my mission to ensure that these reports leave no concerns hanging (e.g. regarding GCP compliance) and raise no suspicion of inadequate monitoring.