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7 safety surveillance
Regulatory V7 I5

Consolidation of Safety Surveillance by Risk Management Strategies: A Status Analysis

Safety surveillance has evolved into a continuing process during the whole drug life cycle. Policy-makers and regulatory bodies have instigated proactive safety assessments during drug …

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8 translation
Regulatory V7 I5

Effective Ways to Manage Translation Requirements over the Lifetime of a CRO Study

At first glance, translation may seem to be a very small part of a large multisite, multinational clinical study. However, over the life of a …

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