Simplifying Global Compliance
Navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life.
Complaint management systems have long been an easy target for FDA inspectors. Come up short in an inspection and the FDA can issue a Form 483 or a warning letter.
You're probably on the fence about employing a risk-based clinical trial monitoring program. Many are, preferring the old methods of 100 percent verification of data — and intense site visits — that they're more familiar with. But the fact is risk-based monitoring with a centralized data monitoring component can actually produce better levels of compliance than the old ways — if it's done correctly. The new FDAnews management report Strategies for Risk-Based Clinical Trial Monitoring and Inspections will show you exactly what 'done correctly' is.
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