Clinical Monitoring And Site Management

Critical to a successful clinical trial is the efficient management and monitoring of clinical sites.

 

7neurons engages a diverse range of specialised staff to perform all aspects of site management and monitoring. We offer an experienced and diverse team of regionally based monitors, our clinical research associates (CRAs) focus on developing strong site relationships while ensuring adherence to data quality, patient safety, and early issue resolution throughout the course of the trial.
 
 
 
Our Central Monitoring group supports sites and patients, overseeing the running of studies and directing strategy throughout the clinical trial process

Clinical Trial Monitoring Activities

  • Full-service monitor visits – qualification, initiation, interim, and close-out
  • Comprehensive monitoring plans
  • Thorough review of site records
  • Timely completion of visit reports
  • Quality review of monitoring reports
  • Source document verification as per monitoring plans
  • Rapid query resolution
  • Site training and support
  • Site management support and documentation
  • Periodic remote EDC review
  • Drug accountability

Clinical Site Management Services

  • Site selection and feasibility
  • Investigator/site contract and budget negotiation
  • Development of recruitment criteria
  • Managing patient recruitment and retention
  • Investigator payments
  • Inbuilt quality assurance mechanisms
  • Good Clinical Practice (GCP) training
  • Communication with sites
  • Customizable training based on the needs of the study

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