KNOWLEDGE CENTER

 

Common Mistake in Adjusting Sample Size for Anticipated Dropouts in Clinical Trials

Day by day the clinical trial field is expanding like anything. New molecules are needs to be experimented in human beings and the existing drugs are needs to be monitored for long term safety. Thus Phase I to IV clinical trial activities are increasing exponentially all over the world.



Clinical Oversight

Recently, U.S. Food and Drug Administration (FDA) issued Warning Letters to pharmaceutical companies and their outsourcing partners have resulted to focus on clinical oversight. The letters have galvanized sponsors to take a close look at their ability to withstand such regulatory scrutiny internally, and to develop proactively their internal capabilities and infrastructure



cQRM (clinical Quality Risk Management)

cQRM is a risk management methodology that applies quality risk management to clinical trials. It focuses on proactive risk management in clinical research and helps in completing clinical trials successfully within the timelines and budget.

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