CLINICAL TRIAL MONITORING

Working closely with project managers, the CRAs on CXN Clinical’s monitoring team are highly experienced, ICH-GCP trained individuals who are equally committed to the success of the study. Thorough knowledge of the trial design, therapeutic area, protocol and product, along with industry regulations and best practices, allows our CRAs to ensure data quality, timely data submission, and protocol and regulatory compliance. Throughout the lifecycle of your trial, our CRAs will provide the following services:

  • Overall site management
  • Site initiation, routine monitoring and close-out visits
  • Site study team training and site coordinator support
  • Study drug accountability
  • Query tracking and resolution
  • Protocol deviation tracking, trend and root cause analysis, and corrective and preventative action (CAPA) development and implementation