Medical Review

Ensuring Patient Safety and Data Consistency

SCiAN's Medical Reviewers work diligently to identify safety issues and ensure data consistency.  Medical reviews can be done independently of or combined with Safety Data Monitoring and can be scheduled either on an ongoing basis or at the end of the trial (prior to database lock).  SciAn offers a customized approach based on the indication and phase of the clinical trial.  Our minimum scope includes:

  • Protocol deviations with inclusion/exclusion criteria
  • Consistency of adverse event reporting and concomitant medication usage
  • Patient termination
  • Medical history vs. Physical Examination
  • Drug Administration.