Services
Your product not only needs to be effective, it needs to be safe. The best strategy to supervise your product’s safety involves continuous monitoring of the risk-benefit profile throughout the lifecycle, so that key findings about the safety of your product can be identified and addressed as early as possible. Ongoing signal detection activities and the development of risk management plans can support you with this goal.
Pharmacovigilance consultancy services support you in the development and maintenance of an efficient pharmacovigilance system as well as in establishing good pharmacovigilance practice in your procedures.
Signal detection activities
- Medical analysis of serious individual case safety reports (ICSRs)
- Safety signal tracking over periodic intervals as defined by product risk and client preference
- Production of formal periodic review and signal analysis reports including formal quality control
Pharmacovigilance consultancy services
- Detailed description of the pharmacovigilance system (DDPVS)
- Development or update of pharmacovigilance SOPs
- Development or update of working procedures
- Pharmacovigilance agreement (PV manual, SAE handling manual) including description of interfaces with other stakeholders
- Eudravigilance registration consultancy and setup of electronic reporting
- Pharmacovigilance training
- Document review (clinical study protocol, informed consent form, clinical study report, investigator brochure, etc.)
Dr. Susanne Kaiser
Director Pharmacovigilance
+49 6196 7709-292
