Ensure Drug and Patient Safety
Pharmacovigilance is the science of medication-related patient safety. We have experts available in every aspect of this critical discipline. Our consultants can forge a smooth path to approval for your pharma breakthrough.
Prevent Adverse Effects
Every new drug must be rigorously proven for efficacy. Knowledge of all potential adverse drug reactions and errors such as overdose is also key. We can ensure there are no gaps in your data and reporting.
Stay Ahead with Monitoring
The World Health Organization has adopted the web-based pharmacovigilance monitoring system PViMS. We have consultants experienced in managing data from the physicians, regulators and contributors reporting through the PViMS system.
How We Can Help
Drug and patient safety is the overriding mission of pharmacovigilance. The process of revealing and addressing potential hazards in pharmaceutical products allows scientists to ensure efficacy while minimizing the risk of harm.
An Individual Case Safety Report or ICSR, gathers and assembles reported data about adverse events, complaints and other product issues. ICSRs are an important part of your pharmaceutical production and approval process.
Unlike individual case reporting, which uses deep data, aggregate safety reporting takes a higher level perspective developed over months or years. Submissions such as periodic reports and clinical findings must be managed continuously.
There is a fine line to balancing risk against the potential benefits of new medications. Regulatory direction of risk management activities in pharma is receiving considerable attention, especially in major markets such as the US and EU.
Data collection, analysis, and monitoring are the drivers of the pharmacovigilance field. Safety signal detection narrows the focus to working with adverse event data. Define and implement the appropriate steps.
More than a million new scientific medical articles are published each year around the world. The ability to find every possible relevant publication while filtering out irrelevant information is a demanding discipline.