Safety reporting processes are required by Health Authorities and necessary to protect patients. Inaccurate, incomplete, or late reporting can negatively impact a development program and may cause risk to patient health.
Health Authorities typically enforce strict timelines for reporting adverse events once they are received by the sponsor organization. The quick turnaround demands the accuracy and speed that is only possible when the organization is adequately trained, processes are optimized, and enabling technologies are implemented to deliver consistent and compliant reporting.
The Red Nucleus team offers the unique combination of cross-functional expertise, process-driven approach, and proven methodology that helps life sciences teams meet and exceed their safety reporting and compliance goals.