The mission of the Data Monitoring & Management (DM&M) organization is to strengthen the oversight of our clinical data through stronger ownership, control, and visibility of our clinical data. This is achieved through operational excellence in:
Definition and monitoring of key risk indicators to enhance our risk-based monitoring (RBM) strategies, and
Monitoring of the integrity and the flow of clinical data from our CROs, external electronic data sources, and third party studies into our internal systems to inform timely clinical development decisions.
The primary scope of this function is from database design to database release.
Selection and application of data acquisition standards,
Data integrity monitoring, and
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