Monitoring

Our experienced Project Managers and our skilled Clinical Research Associates work together as a team to efficiently manage site activity.

Novum Monitoring Services include:

  • Conducting on-site Pre-Study Site Selection and Site Initiation reviews
  • Monitoring on-site Source-to-CRF verification
  • Reviewing documents to ensure regulatory compliance
  • Reviewing Study Drug for appropriate handling
  • Resolving Data Queries
  • Reporting findings to the Project Manager
  • Maintaining Trial Master File
Our team concept allows our Project Managers to manage a study from beginning to end and maintain real-time knowledge of the activities occurring at all sites throughout the clinical endpoint study, while allowing our CRAs to focus on the specific needs of individual sites to ensure the successful completion of each study. In addition, sponsors may contract our monitoring services for Early Phase studies conducted in our clinics.