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Clinical Development
Data Management
We provide overall data management services from CRF (Case Report Form) development to clinical trial database configuration, operation, and management.
Professional services for data collection and management cover all clinical phases including IIT and PMS in various therapeutic areas.
Our staffs have rich practical experience in eCRF development, e-clinical trial solution setup, data cleaning, centralized monitoring and CDISC standard dataset creation, and deliver proven services.
Real time data cleaning for decentralized clinical trials
Real-time data cleaning is a centralized process that continuously monitors clinical data while it is collected and entered into a database, and identifies and corrects errors or inconsistencies in the data in real time.
It involves automated processes and uses software and algorithms to identify data inconsistencies or errors such as missing data, invalid responses, or outliers.
Spero uses its own centralized monitoring system linked to eSource systems, to flag data points in real time for the team to review and correct when errors are identified, and to provide feedback through queries immediately upon data entry.
Process
Service Scope
Data Management Plan
Database Quality Control
Data migration
Customized DB Design
and Validation
Data Review
CDISC standardization
CRF Completion Guideline
Development
Database Lock,
Data Management Report
Medical Coding, SAE Reconciliation,
External Data Management (Lab data, etc.)
Service Scope
Data Management Plan
Customized DB Design
and Validation
CRF Completion Guideline
Development
Data Review
Database Quality Control
Data migration
CDISC standardization
Medical Coding, SAE Reconciliation,
External Data Management (Lab data, etc.)
Database Lock,
Data Management Report
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