Ability to assess early evidence outcomes to optimize late phase trials
Accelerated data deployment and database lock
Increased data autonomy and reduced dependency on multiple vendors
Early Phase Biostatistics | PK/PD Analysis and Reporting |
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Developing Protocol Design | PK/PD Analysis and Reporting |
Sample Size Evaluations | Statistical Analysis |
Randomization Generation | CDISC Standardization |
CRF Review | SAP / SAR creation |
Development of SAP / SAR | POPPK Dataset Programming with ERS and ERE |
DMC/DSUR/Interim SAP | |
DMC Statistician (Unblinded) | |
Query Resolution |
Risk Based Quality Management | Central Support Services |
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Risk Assessment and Implementation | Investigator Payments- Payment Reconciliation |
Central Monitoring | Periodic eTMF Review |
Central Statistical Monitoring | Project Administration Support |