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Medpace CRO Data Management
Data Management


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GENERAL CAPABILITIES




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Working closely with Sponsor project teams, the Medpace data management team develops detailed specifications for the collection, organization, validation, analysis, and quality control of clinical trial data ensuring the most cost-effective, secure, and regulatory compliant process. Our responsive approach, combined with superior therapeutic and regulatory expertise, allows flexibility in accommodating changes to project specifications with minimal to no timeline adjustment, all while maintaining the highest levels of data quality and integrity.

The Medpace Data Management team:

  • Designs case report forms (CRFs), in either electronic or paper form.
  • Performs double-data entry of CRFs (paper only).
  • Validates project-specific components of the data management system during the initial setup and throughout the trial as modifications are introduced.
  • Reviews clinical data for errors or trends and generate electronic queries.
  • Integrates data from external sources to ensure consistency with CRF data.
  • Provides medical coding using standardized dictionaries such as MedDRA, WHO Drug, or Sponsor-specific dictionaries.
  • Delivers a clean, analyzable database in customized formats, adhering to Clinical Data Interchange Standards Consortium (CDISC) standards.
  • Reconciles serious adverse events.
  • Produces clinical trial metrics.
  • Integrates data into the rest of your study.

All clinical data is entered into the ClinTrak Electronic Data Capture module(DM/EDC). ClinTrak DM/EDC provides a centralized work space for the data management team, allowing for secure and accurate treatment of data from each study. This comprehensive tool provides functionality in the areas of study design, data entry, data clean-up, coding of terms, data changes, reporting, real-time web access, audit trail, and export of the clinical data for analysis purposes.

Features include:

  • Custom Designed Data Entry Screens.
    • Designed to mimic case report forms.
  • Case Report Form (CRF) Tracking.
    • Status progression from Received to Locked.
  • Rule-Based Edit Check Engine.
    • Customized rules find and flag incorrect data.
    • Automated execution of jobs as data entry is completed.
  • Data Query Generation and Tracking.
  • Medical Coding.
  • Flexible and Customized Reports.
    • Excel and PDF report formats.
    • Ad hoc report builder