In the world of clinical trials, effective management of Serious Adverse Events (SAEs) is essential to ensure participant safety and the reliability of study outcomes. A streamlined process encompasses steps from accurate reporting by the investigator to thorough review and approval by relevant authorities.
Timelines is vital: SUSARs (Suspected Unexpected Serious Adverse Reactions) should be handled within a tight timeframe, typically within one business day, whereas routine SAEs may be addressed in longer periods. Moreover, addressing urgent and non-urgent queries within set deadlines is crucial for maintaining responsiveness. This careful approach not only safeguards participants but also upholds the integrity of the clinical trial.
At Asphalion, we provide comprehensive support for the management of Serious Adverse Events (SAEs) in clinical trials. Our team ensures that all processes, from reporting to final approvals, are handled efficiently and within required timelines. We assist in preparing and reviewing necessary documentation, such as CIOMS forms, and facilitate seamless communication between sponsors, investigators, and regulatory authorities. By entrusting your SAE management to Asphalion, you can focus on your core research while we ensure the safety and compliance of your trials.
For more information, contact us at [email protected]
Have a look at the infographic here: SAEsSUSARsManagement_PVMonth_Asphalion
