Services

DOT offers both EDC and paper based CRFs and always provides customizable data management services. DOT develops project-specific Data Management Plan(DMP) compliant with the Clinical Trial Protocol and the Statistics Analysis Plan. In accord with all regulatory requirements, guidelines and the DMP, DOT provides all Data Management services from CRF design through Data Cleaning to Database Lock.

DOT's experienced data management team designs an optical check system and an efficient query answering process to make DOT rapidly provide a data cleaning service within our clients' timelines.

DOT supports CDISC (CDASH, SDTM) and other customized data export formats. In addition to study result documents, DOT can provide customized reports such as monthly progress reports, with graphs required by our clients.

  • SCRF Design and Annotation (Paper/EDC)
    • CDASH compatible (when needed)
  • EDC Setup and Validation (using Viedoc TM)
  • Data Management Plan
  • Data Input (Paper CRF)
  • Data Integration and Cleaning
    • Importing External Data (ex. Lab Data)
    • Logical/Manual Checks
    • Query Management
    • Periodic Report (when needed)
  • Coding
  • SAE reconciliation
  • Data Lock
  • SDTM Data Generation
    • SDTM Specification
    • Legacy Data Conversion

JCROA CDISC

DOT WORLD Co., Ltd. Comodio Shiodome 4F, 2-14-1 Higashi-Shimbashi, Minato-ku, Tokyo, 105-0021, Japan