Medical Monitoring

FMD K&L offers a variety of medical monitoring services to ensure consideration of patient safety at every stage, from protocol design to study follow-up
Clinical Operations: Medical Monitoring

FMD K&L offers medical review of study documents including protocols, case report forms, clinical study reports, periodic safety update reports, and regulatory submissions. Our medical doctors bring clinical perspective to assist sponsors and study teams in every facet of participant safety.

Our medical monitoring and medical affairs services include:
  • Therapeutic consultation
  • Investigator brochure development & review
  • Review and evaluation of serious adverse event reports & expedited cases
  • Review of laboratory data
  • Identification & evaluation of safety signals & trends
  • Categorization of protocol deviations & violations, analysis of emerging trends
  • Regulatory agency support & advocacy
  • Study team training on disease states, treatments, protocol adherence, inclusion/exclusion criteria, medical coding & procedures
  • Key opinion leader networking