Pharmacovigilance
Pharmacovigilance, or drug safety, is a critical aspect of clinical trials, encompassing the collection, detection, assessment, monitoring, and prevention of adverse effects associated with pharmaceutical products.
Recognizing the importance of pharmacovigilance, we are dedicated to providing comprehensive pharmacovigilance services. Our commitment entails monitoring, assessment, and accurate reporting on the safety of both investigational and approved products. Our goal is to promptly detect any changes in their risk-benefit profile, ensuring the ongoing safety and well-being of trial participants and patients.
We operate in close collaboration with sponsors, sites, and regulatory authorities to uphold compliance with all pertinent reporting obligations. Our dedicated service includes thorough monitoring of medical journals and government publications to identify any serious or adverse events (S/AEs) and emerging trends, ensuring timely reporting as required.
Serious Adverse Events (SAEs) may arise during clinical trials or be reported by participants or healthcare professionals unexpectedly. We understand that unexpected adverse events can occur at any stage in the lifecycle of a product. Therefore, we diligently gather safety data throughout the product’s lifecycle, utilizing state-of-the-art software to collect and verify this information. Our priority is to ensure the timely reporting of safety concerns to the relevant regulatory authorities, maintaining the highest standards of pharmacovigilance.
Our team of expert pharmacovigilance associates oversees and manages the regular development of pharmacovigilance activities. They are responsible for monitoring and reporting on drug effectiveness while ensuring the prevention of adverse effects associated with these products.
