Clinical safety

FMD K&L can assist in developing accurate safety profiles of new consumer health products and investigational drugs
Clinical Operations: Clinical safety
Our comprehensive set of clinical safety services, includes:
  • Toxicology assessments of active & excipient ingredients
  • Collection, evaluation, analysis & reporting of safety information
  • Preparation of safety narratives with physician review
  • Coding of adverse event information, including MedDRA & WHO coding
  • Assessment & reporting of safety events to global regulatory authorities, including EudraVigilance reporting & EU e-reporting
  • Preparation & submission of annual & periodic safety reports
  • Safety surveillance of clinical trial data for adverse events & laboratory trend analysis for detection of safety signals