Ensuring the safety of our client’s patients while maintaining compliance with regulatory requirements
In order to meet ever-changing regulatory requirements, our dedicated staff conducts literature searches to help ensure the safety of our clients’ patients.
The volume and complexity of data sources continues to grow. We search a variety of sources for a variety of outcomes. These include identification of individual case safety reports (ICSRs) from international literature; potential safety findings; any additional information that may have an impact on the benefit-risk assessment of the products and/or active ingredients; and any findings which may pertain to periodic safety update reports (PSURs).