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Improving Quality Using Centralised Statistical Monitoring

As the dust begins to settle after the ICH Good Clinical Practice E6 (R2) Addendum, the importance of data oversight and integrity should still not be overlooked. It has become increasingly important to the FDA after the Addendum and likewise for the sponsorís responsibility to ensure quality management over regulatory submissions.

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Thomas Underwood, Marketing Manager at Quanticate, has over 10 yearsí experience within the life sciences industry. Originally working in operations in both clinical data management and programming, he moved into the commercial division and has been in his current role for over eight years. An integral part of Thomasí role is product development, involving extensive research into industry regulations and the resulting technology and services these influence, such as risk-based monitoring, data quality oversight, and centralised statistical monitoring. He has a postgraduate professional diploma with the Chartered Institute of Marketing and secured Chartered Marketer status in 2014.
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