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BioPharma’s full offering of Data Management services includes:

  • Data Management Plan (DMP) development

  • eCRF design and development

  • Database Build & Design

  • Data validation specifications

  • Data Management

  • Edit checks Programming & Testing

  • Collection of pharmacodynamics data and review

  • Single or double data entry

  • EDC Training

  • eCRF Completion Guidelines

  • Query Management

  • Third-party data integration

  • Customized clinical data management programming

  • Safety Data Management & Reconciliation

  • Data Export/Transfer

  • Interim Analysis readiness

  • Medical coding (CM, AE, MH)

  • Serious Adverse Event (SAE) reconciliation

  • Customized status reporting and data listings

  • Database closeout and delivery

Our comprehensive CDISC data conversion services include:

  • SDTM annotated CRFs

  • SDTM datasets

  • ADaM analysis datasets

  • Pooled analysis datasets (ISS/ISE)

  • Define.xml metadata and Define.pdf

  • CDISC controlled terminology

  • Data Handling report

  • FDA reviewers’ Guide

  • eCTD structure

View our other Services