Case Management

Each marketing authorisation holder has to ensure that any safety relevant information is evaluated properly and subsequently reported as an ICSR or SUSAR, if applicable. Our experienced personnel can support you with (suspected) ADR and SAE assessment to comply with regulatory requirements.

Case management meeting the requirements set out in GVP module VI “Management and reporting of adverse reactions to medicinal products” includes:

  • Professional (medical) assessment of suspected ADRs and adverse events
  • Identification of reportable cases and information relevant for Signal Management and CoBRA®
  • Quality controlled documentation of all activities

Our Concept

We offer you our complete service for case management which comprises collection of safety relevant data by literature search, assessment of suspected ADRs from the literature, competent authorities and the spontaneous reporting system as well as electronic reporting. It is up to you whether you involve us in all steps of case management or if you only want to outsource certain activities to us. Our competent personnel comprising physicians, scientists as well as medical data managers are at your service:

  • Collection of safety relevant data from the scientific literature and competent authorities
  • Case entry into the safety database
  • Assessment of ADRs regarding seriousness and listedness, as well as causality assessment
  • Narratives in English or German (or other languages, e.g. Spanish)
  • MedDRA coding of adverse drug reactions

Please do not hesitate to contact us for an individual offer.