• Diverse Clinical Study Build Expertise: Specialize in clinical study builds, offering professional guidance, advice, and strategic planning across various studies and therapeutic areas.

  • Custom EDC Study Setup: Build EDC database with data management and programming skills, incorporating optimized CRF designs for efficient data entry and data extract.

  • Data Quality Assurance: Develop or assist in the creation of advanced data validation rules and edit checks to ensure high data quality.

  • EDC Standards Development and Optimization: Formulate and refine specific EDC backend setup standards, naming conventions, and procedures, complemented by checklists, to achieve consistent and replicable study builds in multiple areas.

  • Management of EDC Study Amendments: Handle EDC study amendments effectively through comprehensive impact assessment, stakeholder communication, system updates and testing, as well as ongoing training, support, and enhancement.

  • External Data Ingestion: Create specifications for external data that align with SDTM mapping to facilitate the ingestion or loading of data.

Electronic Data capture (EDC) and External Data Ingestion