Benefit risk management
Benefit risk management verifies that benefits of a medication continue to outweigh the risks ensuring patient safety with medicinal therapies.
We support clients to prioritize patient safety and regulatory compliance with benefit risk management solutions, helping them navigate complex healthcare landscapes, decision-making, and successful outcomes.
Benefit risk management
Benefit risk management encompasses assessment of safety of therapies across all phases of their life cycle through cross functional collaboration of different pharmacovigilance and regulatory teams.
Risk management plan (RMP)
The RMP showcases current knowledge about safety and efficacy of a therapy, and provides vital information on plans such as studies, to gather knowledge and recommend measures to mitigate or prevent associated risks.
Risk evaluation and migration strategy (REMS)
REMS is a safety program required by US FDA for therapies with serious risks to ensure the benefits of the medication continue to outweigh the risks.