The face of clinical compliance is changing based on regulatory and technological advances. Long accepted industry standard practices require change. These changes are impacting pharmaceutical companies as well as their service providers. Quality professionals are key partners for ensuring that appropriate industry changes continue to reflect current regulations and protect patient safety. This symposium features clinical quality assurance experts who will address one of these key aspects of our changing environment: regulatory, technology, and service.

Learning Objectives:
Define the eClinical environment, and the changing role of quality assurance (QA) with that space
Describe how the QA professional should dive in during eClinical audit activities
Discuss the GCP audit implications of the new FDA clinical monitoring guidance document Identify how recent regulatory changes and focus are impacting CRO quality assurance, both internally and for sponsors.