Clinical Safety Surveillance1

Clinical Safety Surveillance

The vigilare Safety Surveillance group represent years of experience in clinical research and safety reporting. Our Team of consultants helps our clients develop clinical testing plans consistent with the stage of preclinical development and FDA requirements.They join clinical and pharmacological expertise with extensive knowledge of regulatoryrequirements and processes to provide our clients with unparalleled speed, efficiency, and thoroughness in reporting adverse events (AEs).We can help identify the key preclinical safety issues, and devise a testing plan to address them in the most cost-effective approach

Safety Surveillance capabilities include

  • Protocol, forms, and process design
  • Regulatory reporting to Governing Agencies
  • Site education
  • Follow-up on serious Adverse Event(AE) Detection
  • AE dataCollection, clinical review.
  • Medical monitor AND safety data evaluation
  • Maintenance AND Safety database creation
  • Investigator Alert letters distribution and creation
  • Toxicology risk assessment for human exposure and clinical trials
  • Clinical narrative writing for final study reports(AE reports)
  • Reconciliation of clinical databases and safety

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