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