Usually part of monitoring responsibilities offered by VERUM this is also offered as stand-alone service. Safety Surveillance covers all activities from the notification of an occurred SAE until the completed SAE is ready to be forwarded to the Client’s Drug Safety ( Pharmacovigilance) department for medical assessment and notification to authorities and EC’s. Our specialists have up to 20 years experience in this particular field.
contain SAE and/or Clinical Event Processing at VERUM (from first notification via CIOMS form or by phone, clarification with the clinical site’s staff until completion of the patients case and forwarding to the Clients Drug Safety)
include also Medical Assessment (if delegated by Client or in Cooperation with Client)
Close follow up with Authorities and
client until approvals are obtained
provide medical translations of supportive adjudication documents into English
capture Medical Coding of Medication (WHO-DD), Diseases and Adverse Events (MedDRA)