Our medical experts play an important role during the study in providing medical review and medical monitoring services. Looking beyond the patient level, we identify trends at patient group level, which allows us to inform physicians and sponsor about the investigational drug’s safety and efficacy profile early. In addition, we provide valuable feedback on study design and can help you optimize your product’s entire development path.
Throughout the course of the study, SMS-oncology’s medical affairs team comprising of MD/PhDs experienced in oncology can be available 24/7 to answer medical questions or provide site support. We can perform a full medical review on a patient-by-patient level or on a group level to ensure patient safety and data integrity. We can also check data collectively to identify trends and hence extend risk-based monitoring if necessary.
We continuously assess each project for therapeutic response, and have discussions with CRAs to ensure safety issues are identified early. Our CRAs are especially aware of the importance of safety reporting and collaborate closely in the correct reporting of adverse events (AEs).
Our medical affairs team is experienced in setting up and chairing dose escalation meetings. By monitoring sponsor needs and patient wellbeing, we can strike a balance between required recruitment speed and patient safety. As an essential part of our Medical affairs activities, we additionally provide end-to-end Pharmacovigilance services.