About 5th European Clinical Trials Inspection Readiness

The 5th European Clinical Trials Inspection Readiness Summit is intended to deliver best practices when maintaining a culture of preparedness when dealing with data integrity, data privacy, and good clinical practice (GCP). This will be a great opportunity to discuss sponsor oversight strategies when dealing with regulatory agencies and ultimately staying prepared for inspection throughout the clinical trial process.

When ensuring your organisation is fully prepared for an inspection, you must focus on key areas including quality, data integrity, and data maintenance. With the FDA, EMA, and the MHRA each providing their own unique guidelines to follow, it can be difficult and time-consuming when attempting to prepare for these inspections, which can be unannounced.