CLINICAL DATA MANAGEMENT

Due to Clinical Trial’s increasing cost, complexity, adherence to regional, national & international regulations, regulatory review process and updating in technology, Bio- pharmaceutical companies are under tremendous pressure to identify opportunities that, reduce clinical trial cost, increase efficiency, improve cycle time and streamline R & D process.

IICRT Offers a full range of Clinical Data Management Services, that can be customized to meet our client‘s specific requirements, IICRT is well equipped in performing Clinical Data Management activities leveraging both Electronic Case Report Form (eCRF) and Paper Case Report Form (pCRF) process throughout the clinical development phases. Our Services are supported by diverse electronic Data capture software platforms, exhaustive SOPs, tools and systems.

  • Case Report form design, review and annotation.
  • Experience with multiple database platforms including Medrio, Data Labs, MedidataRAVE, ORACLE Clinical RDC, and INFORM.
  • Database Design. Development, Validation, and Maintenance.
  • Query Management for decision-ready data.
  • Medical coding for adverse event experience clarity.
  • SAE and External data source reconciliation for consistency of reporting.
  • Standard and custom reporting to enable data visualization.
  • EDC, paper, and hybrid data collection design to cover all scenarios.
  • Integration with IVRS, central labs, and other associated system for efficiency and data consistency

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