Safety Document Exchange in the Global Clinical Research Environment
White Paper Jan 24, 2012
Not long ago, the public assumed that drugs approved as safe and effective by the FDA were, in fact, safe and effective. But a series of highly publicized product withdrawals and black box warnings given to marketed drugs in recent years has alerted the public and Congress that the FDA must give greater scrutiny to safety signals arising during drug development. As a result, the proper and timely reporting of Serious Adverse Events (SAEs) during clinical trials is under scrutiny.
Serious adverse event (SAE) reporting can have severe repercussions both for patient safety and company reputation. By choosing a portal solution from a SaaS provider with state-of-the-art online security features, a sponsor or CRO can maintain real-time distribution and access reports for all documents shared, helping maintain compliance and data privacy.