Benefit From Faster Study Startup with Expert Support

We provide highly professional, rapid, and exacting clinical data management services. Our experienced staff assure the reliability of your study’s data, in accordance to Good Clinical Practice (GCP), Good Post-marketing Study Practice (GPSP) and other related regulations. We support product development from clinical studies to post-marketing surveillance.

CMIC provides global coverage for data management services, with offices in Japan, South Korea, and Vietnam.

Our Edge in Data Management

Services with high-added value and quality

  • We provide large scale operations in data management center (for example, monitoring over 20,000 cases for one project).
  • Work specifications are built by CDISC-trained staff for SDTM data conversion.
  • We provide services with added high quality and value.

Services

Data Management and Electronic Data Capture (EDC)

  • Data management plan, procedures creation
  • eCRF screen designing, structuring support
  • Database specification creation (pCRF trial)
  • Database construction (Audit trail system applied, pCRF trial)
  • Data validation specification designing and edit check structuring support
  • Data entry guideline creation
  • User training conduct
  • Management of sites’ users and employees
  • Status control for trials
  • Data entry (pCRF trial)
  • Computerized-programmed check
  • Manual check conduct
  • Query management (Creation, sending, and closing)
  • Data clarification form (DCF) creation (pCRF trial)
  • External data import management (Regular import completion confirmation)
  • Lab data from central lab, e-Diary, IVRS data and EDC data integration with confirmation on consistency
  • Coding activity for safety and concomitant medication data collected by EDC
  • Management and transfer for EDC-collected-SAE information
  • Output creation for case examination
  • Data management report creation

Project Management

Clinical Operations

Statistical Analysis

Pharmacovigilance

Quality Assurance

Medical Writing

Consulting Services