Adverse Event Reporting

Our safety team can assist with the timely and accurate reporting of adverse events (AEs) and serious adverse events (SAEs) in accordance with regulatory requirements. We can help you develop and implement a customized adverse event reporting process to ensure that all AEs and SAEs are identified, collected, and reported in a timely and efficient manner.

Signal Detection

We can also assist with signal detection, which involves the identification of potential safety signals or trends in clinical trial data. Our team can help you develop and implement a customized signal detection process to ensure that all safety signals are identified and appropriately managed.

Our safety monitoring services include:

• Adverse event reporting
• Safety signal detection and management
• Safety data reconciliation
• Safety database management
• Safety monitoring plans
• Safety reports

Our safety specialists have extensive experience in pharmacovigilance and are trained in compliance with regulatory guidelines and industry best practices. We can work with you to develop a customized safety monitoring plan that meets your specific study needs and budget.

Contact us today to learn more about how we can help you ensure the safety of your clinical trial participants through our safety monitoring services.