It’s all about assessment, understanding, and prevention of adverse effects or any other drug-related problem. Pharmacovigilance (PV) is extending knowledge of safety. Patient safety is a key component and imperative in all clinical trials – whether it’s drugs or devices, it cannot be registered and get to market unless proven to be safe. For all medicines, there is a trade-off between the benefits and the potential for harm.During a clinical trial the rules and laws are strict on safety: what, who, when, where and how to report.
We are used to handle trial-related patient safety from case processing and medical evaluation to submission of safety data to regulatory authorities. We prepare and submit periodic reports. We have expertise in multiple therapeutic areas. The safety staff is familiar with safety reporting practices and regulations.