Best Practices in Signal Detection Management

Timely and effective signal detection is crucial to establishing safe use of medicines, optimizing their efficacy and meeting regulatory expectations. It is a significant driver of time- and cost-effective drug development, catching signals before they become safety issues and avoiding the need for additional studies.

Signal detection is also pivotal to post-marketing commitments. It enables companies to address regulatory concerns proactively. It informs label discussions and adjustments. Most importantly, it averts harm to patients from risks that could not have been recognized earlier.

Approaches to signal management do, however, vary between biopharmaceutical companies. In this white paper, we look at the key factors driving this divergence, so that companies can direct their signal-detection processes to maximum benefit.