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.