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Expertise - Safety management

Pharmacovigilance/Safety management

With the continuous monitoring of the study we provide an indispensable safety to our customers. Hence, the central task of our pharmacovigilance team lies in the registration and timely handling of reported Serious Adverse Events (SAEs).   Here we assist our customers in completing regulatory requirements and adherence to deadlines (AMG, GCP-V).   Our competencies in this context include:

  • SAE registration and listing
  • MedDRA coding of SAEs
  • Inquiries to obtain additional required information
  • Obtaining assessment by the sponsor or representative thereof
  • Preparation of case narratives and reporting of SUSAR-single case reports in CIOMS-format
  • Reporting of SUSAR to the federal authority, ethics committee and to all investigators participating in the study
  • Completion of annual safety report