Clinical Monitoring

FMD K&L clinical research associates (CRAs) monitor project functions and parameters to ensure study integrity throughout the clinical program
Clinical Operations: Medical Monitoring

Our CRAs rigorously monitor clinical activities at every study stage from site qualification to closeout. The hallmark of our services is strict attention to every detail.

Our services may include any portion of the following, including an end-to-end solution:

Site qualification visit

  • Space evaluation
  • Clinical staff interviews
  • Equipment inspection
  • Prestudy screening visit

Site initiation visits

  • Review of protocol, investigator brochure, and regulatory documents
  • Electronic case report form (eCRF) training
  • Review of procedures for safety reporting, query handling, and drug management

Interim monitoring visits

  • Review informed consent form (ICF) completion
  • Confirm HIPAA compliance
  • Verify patient eligibility
  • Monitor protocol violations and/or deviations and adverse event reporting
  • Handle query resolution
  • Examine and report reasons for participant withdrawals
  • Perform drug accountability

Closeout visit

  • Finalize documentation
  • Prepare for any pending regulatory agency audits
  • Perform final study drug accounting
  • Review study termination obligations with site personnel