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Pharmacovigilance and Safety
Safety and Pharmacovigilance


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GENERAL CAPABILITIES




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The Clinical Safety team is a highly-trained and experienced staff composed of healthcare related professionals who handle global pre-authorization adverse event management for pharmaceutical (chemical and biologics) and device trials using a global safety reporting database. Clinical Safety team members have healthcare related degrees to better manage case compliance and quality when performing the services offered.

Services offered include the following:

  • Collection, evaluation, analysis, and reporting of safety information, including serious adverse events, unanticipated adverse device effects, and other significant safety events
  • Safety narrative writing including physician review
  • Coding (MedDRA, WHO Drug) of adverse event information
  • Assessment and evaluation of reportability and submission of reportable events to global regulatory authorities, EudraVigilance reporting and e-reporting in the EU
  • Experienced certified users of EudraVigilance
  • Provide expertise on safety-specific national regulatory requirements in many countries worldwide
  • Preparation and submission of annual safety reports, six monthly line listings, and periodic reports to global regulatory authorities
  • Custom safety surveillance including adverse event and laboratory data review and trend analysis
Want to learn more about ClinTrak? Visit ClinTrak®