Precise safety handling is crucial in defining the risk-benefit ratio for anti-cancer therapies. Especially in the early stages of drug development, the emphasis is on identifying the safety profile of a new compound. SMS-oncology can assist in anticipating, discovering and reporting adverse events (AEs).
As an essential part of our Medical affairs department, SMS-oncology offers fully compliant and high quality comprehensive pharmacovigilance services. We are capable of setting up and performing all required safety handling management services (recording and reporting) in Europe and North America.
Our pharmacovigilance managers are certified by EMA as EVWEB and XEVMPD users in the Eudravigilance system. For North America, SMS-oncology will handle the submissions to the Health Authorities via MedWatch form (USA submissions, FDA) or CIOMS (Canada).
- Registering sponsors with Eudravigilance
- XEVMPD entry and maintenance
- Appointed as Responsible Person (RP) for Eudravigilance
- Serious Adverse Event (SAE) processing (initial / follow up reports)
- Narrative writing
- Global expedited case reporting (EU and US)
- Aggregate report preparation and reporting (e.g. DSUR, semi-annual line listings)
- Monthly compliance and status reporting
- SAE reconciliation
- Unblinding services
- Performing pharmacovigilance activities as governed by Safety Data Exchange Agreement (SDEA)
- (global) Safety database set up and maintenance
- Legacy data migration (safety data transfer from company to another)
RFP or protocol advice?
Would you like to request a proposal (RFP), or interested in getting a free and confidential review of your planned early phase oncology trial (draft) protocol? Use the forms below: