Safety & Vigilance

Services and Know How

Accovion offers you full-service Safety & Vigilance solutions, including support for the regulatory transition of your product from submission to registration. Our highly skilled and experienced team ensures continuous case management and ongoing data analysis.

Case Management

  • Clinical trials (Phase I to Phase IV including NIS)
  • Post- marketing surveillance (Spontaneous, Literature, AWB, Authorities)
  • Medical Devices
  • Experience in Clintrace™, ARISg™ and Argus Safety™ including user support and training, data retrieval and compliance monitoring
  • MedDRA and WHO Drug coding expertise
  • Regulatory reporting to Authorities, Investigators and Ethics Committees
  • Electronic safety  reporting via EudraVigilance
  • Support in EudraVigilance registration including Person Responsible for EudraVigilance
  • Maintenance of XEVMPD (Extended EudraVigilance Medicinal Product Dictionary)

Aggregate Data Analysis and Signal detection

  • Development Safety Update Report (DSUR)
  • Periodic Safety Update Report (PSUR)
  • Risk Management Plan (RMP)
  • Safety Management Plan and Standard Operating Procedure development
  • Signal detection, validation and evaluation

Literature review services

  • Literature search by an established service provider and Literature review
  • Medical review and writing services
    • Document review (Clinical study protocol, Informed consent form, Clinical study report, Investigator brochure, etc.)
    • Medical review of individual and cumulative subject data, including Clinical database and lab / examination listings
  • Accovion’s Argus Safety™ database
    • Validated and 21 CRF part compliant environment
    • Highest security standards
    • Regular MedDRA updates
    • Extensive in-built validation and quality checks
    • Database hosting 

Edelgard von Kries

Edelgard von Kries
Head of Safety Operations

+49 6196 77 09 - 217