Pharmacovigilance Analytics & Benefit/Risk Assessment

From spontaneous reporting to data mining and active surveillance, we’ll guide your signal detection strategy.

Risk/benefit assessment is vital during the whole life cycle of products. For each drug one must weigh benefits against the risks, most often in specific sub-populations. Clinical trials provide this information based on a limited number of patients and for patients with very specific characteristics prior to approval. However, once a new drug is used in clinical practice by many patients, new adverse reactions, e.g. very rare ones, might emerge that had not been previously observed in clinical trials.

Therefore, it is necessary to continuously monitor the benefits and risks of the drugs once marketed to ensure that the benefits still outweigh the risks. YOLARX’s extensive expertise in pharmacovigilance will allow you to put in place the appropriate activities and tools to detect, assess, understand and prevent adverse reactions and other drug-related problems ensuring the patients’ safety. For example, we have developed quantitative and semi-quantitative processes for signal detection that have passed regulatory inspections.

Examples of Activities:

• Periodic benefit-risk evaluation reports (PBRERs) review
• Signal detection using safety database or administrative claims databases
• Signal workup
• Active pharmacovigilance / case-population studies
• Background rates in target population
• Modeling (Bayesian) and multi-criteria decision analyses