Pharmacovigilance is commonly known as drug safety. In a contract research organization, pharmacovigilance tasks are related to collection, assessment and monitoring adverse events related to the sponsor's investigational products. The pharmacovigilance team works collaboratively with investigators and the study team to collect serious adverse event and adverse event reports from sites. The team also produces safety reports in compliance with regulatory requirements for sites and sponsors and submits them to ethics committees (ECs) and regulatory agencies.
EPSI has assembled a highly skilled team to support clients. Because our pharmacovigilance teams are based in Japan, China and the Philippines, we can assure enough qualified team members to support studies conducted in Asia. For global studies involving the EU and US, we work with partners to ensure that we provide sufficient support to our clients globally.
Our pharmacovigilance team works alongside the medical team, data management, and clinical services to provide safety reports throughout the study.
A full range of pharmacovigilance services that are your assurance of successful clinical trials.