ICH E6 (R2) requires sponsors to maintain responsibility for oversight of vendors, including those handling your clinical trial data. This often is challenging, particularly for companies with limited or no biometrics departments internally. Correct and effective data oversight increases your confidence in your clinical trial results and supports progress of development programs. During this webinar, we will review the components of biometrics oversight, assess various approaches, suggest an effective data oversight strategy and present case studies. The key learning outcomes will be:

• Understanding of the importance of oversight for clinical trial data

• How to choose the right approach to data oversight

• What are the fundamental components of an oversight program

For more information click here


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