Data Management

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We have we embedded RBQM to proactively monitor critical variables, compress database lock & top-line-results timelines with a process tailored for speed and the quality applying Quality By Design to ensure data is complete, correct and consistent from the start, not at the end.

Keys to Successful On-Time Quality Data:

• Data Management Vendor Selection
• Contract Negotiation
• Vendor Management
• Timeline Management
• Electronic Case Report Form (eCRF) design
• Database build in EDC system
• EDC setup including User Acceptance Testing (UAT)
• Data Management Plan (DMP)
• CRF Completion Guidelines
• Programming of Complex Edit Checks
• Data Review and Query Management
• Third party Data Reconciliation (Central Labs, SAE Database)​
• Thesaurus coding management- Safety Data and Concomitant Medications
• Database Lock and Archive