Determining drug safety
The benefits of a medicine must be weighed against its side effects. The acceptable level of risk is decided upon by the organisation developing the therapy, by the regulators who approve it for clinical development, and ultimately by healthcare professionals in consultation with their patients. Pharmacovigilance is essential for ensuring market drugs are safe and reliable.
Our pharmacovigilance services monitor and assess the possible risks of medicine throughout development, with a core focus on drug safety. Through pharmacovigilance clinical trials, clinical safety data are collected and continuously evaluated throughout the clinical development process. This data are used to assess and monitor the incidence of adverse drug reactions (ADRs) so they can be fully understood, and any necessary adjustments made to dosing advice, contraindications etc.
Risk Management Plans (RMPs)
All applications for products in the European Union (EU) require the submission of a Risk Management Plan (RMP).
A Risk Management Plan (RMP) should focus on the most important safety concerns, thereby prioritising the issues which are likely to have the greatest impact on patients. Effective Risk Management Planning is collaborative and requires input from multiple stakeholders.
Our pharmacovigilance services can include RMP development, working with internal and external stakeholders. It integrates seamlessly with our signal management services for a streamlined process. For example, we calculate and categorise each signal’s risk and assess their impact on the benefit-risk of the product. We then advise on any requirement to update the Risk Management Plan.