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Clinical Data Management

Clinical Data Management Is Recommended As A Dedicated Website Service Covering The Controlled Flow Of Clinical Data From Collection Through Cleaning, Reconciliation, Database Lock And Transfer.

Our clinical services

Clinical Data Management

Transforming Clinical Data into Accurate, Reliable & Decision-Ready Insights

Clinical Data Management Scope

  • Data Management Plan (DMP)
  • CRF / ECRF Design And Annotation
  • EDC Study Build And User Acceptance Testing
  • Database Design And Edit Checks
  • Data Validation And Query Management
  • External Data Integration And Reconciliation
  • Laboratory And Central-Vendor Data Management
  • Adverse-Event And Concomitant-Medication Data Review
  • Medical Coding Using Controlled Dictionaries Where Applicable
  • Data Review Listings And Discrepancy Management
  • Data Quality Review And Metrics
  • Database Lock And Controlled Data Transfer

Clinical Research Delivery Flow

  1. Feasibility & Design
  2. Set-up & Regulatory
  3. Site Activation & Recruitment
  4. Monitoring & Oversight
  5. Database Lock & Analysis
  6. CSR & Close-out

CDM Deliverables

  • CRF Completion Guidelines
  • Annotated CRF
  • Edit-Check Specifications
  • Reconciliation Reports
  • Final Clean Dataset
  • DMP
  • Data-Validation Plan
  • Coding Conventions
  • Data Review Listings
  • Database-Lock Package

Data integrity principles

  • • Attributable
  • • Legible
  • • Contemporaneous
  • • Original
  • • Accurate
  • • Complete
  • • Consistent
  • • Enduring
  • • Available

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