Risk-Based Monitoring

(Image: Getty/masterzphotois)

The biggest paradigm shift in decades? ICH E6 R2

By Melissa Fassbender

ICH E6 R2 sparked a paradigm shift, though 2019 will see the clinical trials industry transition from a risk-based monitoring approach to risk-based quality management.

(Image: Getty/RamCreativ)

Quanticate taps CluePoints for data quality oversight

By Melissa Fassbender

Quanticate is using CluePoints’ software to perform data integrity checks on all types of monitoring and investigator site data as part of its new Data Quality Oversight service.

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