Different standards and requirements apply to clinical trials conducted within the European Economic Area. With our expertise in the specific field of pharmacovigilance we are putting our focus and intentions on ensuring subject safety and guaranteeing to fulfill all necessary regulatory requirements when conducting clinical trials within the European Economic Area.
- Allocation of a legal representative within the European Economic Area for Sponsors based outside the European Economic Area and conducting clinical trials within the EEA.
- Registration of Sponsor at European Medicines Agency’s Eudravigilance Database according to European Legislation.
- We provide a responsible person for Eudravigilance, who is in charge of
- Submission of IMP information to EMA’s XEVMPD database according to Article 57 of EC Regulation No 276 / 2004.
- Submissions of SUSARs as ICSRs to European Medicines Agency’s EVCTM database according to European Legislation.
- Registration of MedDRA license for Sponsor, if applicable.
- Review and consultation for Study Protocol writing regarding safety measures.
Full SAE & SUSAR Handling:
- Preparation, Set-Up and Implementation of SAE Report Form and Pregnancy Report Form.
- Preparation of safety handling instructions and trainings for Investigators.
- Full SAE handling and management from Initial to Final version, creation of CIOMS for each individual case until finalization of the event.
- SAE follow-up requests and query handling with investigators until case resolution.
- Assistance in DSUR preparation for Sponsor and allocation of corresponding line listings of AEs and SAEs/SARs.
- Additional reporting of SUSARs to CAs, ECs and Investigators.
- Allocation of a Study Safety Officer.
- Consequent monitoring of AEs and SAEs throughout the study.
- Study Safety Officer Medical Review of SAEs.
- AquilaCTPV implementation - Instantaneously be up-to-date on all serious adverse events in your study at all time.
- Instant E-Mail notifications in case of SAEs and follow-up information.
- Organization and Set-Up of a Data Safety Monitoring Board/Data Safety Committee