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Clinical Research / Monitoring
It’s been three years since ICH added the E6(R2) addendum to its Good Clinical Practice guidelines. The addendum was intended to create harmonization between US and EU clinical research...
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Clinical Research / Monitoring
It’s been three years since ICH added the E6(R2) addendum to its Good Clinical Practice guidelines. The addendum was intended to create harmonization between US and EU clinical research...
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Quality & Validation Technology Insights
This year, the 35th Annual SQA Meeting and Quality College was home base for many of the Advanced Clinical Quality and Validation team members. With three of our teammates residing in the...
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Clinical Research / Monitoring
There is a difference between running a clinical research trial at a top ten pharmaceutical company and running one in a small to mid-size biopharma. The challenges are different, the...
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Quality & Validation Technology Insights
The use of electronic records in clinical research is growing in practice and complexity for Sponsors, investigators, IRBs and CROs. As a response to that growth in 2017, the FDA issued a...
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Like the foundation of a new house, data plays a fundamental role in the management, monitoring and analysis of results for a clinical trial. Data sheds light on what direction to take a...
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