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Risk approach comes to site monitoring
An emerging risk-based approach to site monitoring uses partial source document verification in place of traditional full source document verification (SDV) coverage. In the risk-based approach, monitoring targets the most critical review activities at sites requiring the highest level of attention. Article
UK study supports dose-response modeling
Researchers studying an overactive bladder treatment have concluded that dose-response models can be used to predict outcomes for doses not studied. Article
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- Roche announces Operational Excellence initiative
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- Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
