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’s team of certified pharmacovigilance managers provides end-to-end safety services tailored to your needs. 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). All our procedures will be described in the project-specific safety handling manual which is written in close collaboration with our clients.
Once a year, a Development Safety Update Report (DSUR) will be prepared for submission to the IECs and CAs of all countries where a trial with the study medication is being conducted. We can also assist sponsors with the updates of safety information in the Investigator Brochure.