Risk management programs
Smooth Drug Development offers full-service solutions in risk management programs.
Risk management programs are conducted to ensure that the drug is prescribed correctly, to reduce side effects and to monitor safety during the course of treatment. Normally it includes screening procedures before treatment start, monitoring of safety parameters during the treatment and defined criteria of discontinuation. These programs include collection of safety data and product complaints.
Risk minimization activities include:
- Development of Risk Management Plan based on previous clinical trials and other safety data
- Development of educational materials about the medicine and its use (patient information brochures, visual aids, physician prescribing guides/checklists, pharmacist dispensing guides/checklists, health care provider letters)
- Development of training programs (patient- or physician-oriented)
- Assurance of restricted use of the medicine (e.g., for use/dispensing only in hospital or where resuscitation equipment is available)
- Special training or certification for health care professionals who prescribe or dispense the medicine
- Assurance of dispensing the medicine only in certain settings (e.g., in a hospital) or with evidence of safe use conditions (e.g., laboratory test results).
- Monitoring or registration of each patient using the medicine
Our risk management services can be implemented separately or alongside our patient support programs to ensure the proper coordination of mandatory testing, including reminders and alerts for healthcare providers.
Smooth Drug Development, a leading drug development company in Russia, CIS and Baltic countries, provides risk management programs since 2016.