Clinical Data Management

EBERS Solutions provides comprehensive data management services, ensuring the highest standards of data quality throughout the clinical trial lifecycle. From study setup and data collection to rigorous validation and cleaning, we maintain the accuracy, completeness, and regulatory compliance of your data. Our team collaborates closely with you to ensure seamless data flow, enabling informed decision-making at every stage of your study.

Clinical Data Accuracy
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Study Start-up

  • Review of Protocol and other Study
  • Documents, CRF Development
  • Development of Data Management and
  • Validation Plans
  • Selection of EDC System
  • Database set-up according to SDTM
  • Validation of Clinical Database before Go Live
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Conduct Phase

  • Cleaning and Validation of Clinical data
  • Query Management
  • Medical Coding using MedDRA and
  • WHODrug Dictionaries
  • Serious Adverse Event Reconciliation
  • Transfer and validation of external data
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Database Lock

  • Final Review and Validation of clinical data
  • Delivery of clean datasets
  • Full data management document package to eTMF
  • Database Lock and Archiving
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