Clinical data management

We provide complete and comprehensive clinical data management solutions from study start through clinical database lock for all clinical study phases i.e. Phase I to Phase IV, with both for FSP Model as well as stand-alone projects. Our Clinical Data Management (CDM) team extends its best practices from across our existing capabilities of statistical software products and services.

We support this, by using best-in-class technology, with 21CFR compliant tools, to provide time based, reliable and reproducible results to our small and mid-size Pharmaceutical and Biotechnology companies across the globe.

Clinical programming services include statistical programming, summary and statistical reports for non-clinical and clinical studies, including:

  • Project management
  • On- site and off-site CDM services
  • Data management plan (DMP) development
  • Paper CRF/eCRF design and development
  • Query tracking and query management
  • Medical coding for medical history and adverse events (ADR/AE)
  • Safety data management & reconciliation
  • Laboratory data reconciliation
  • Data export/transfer
  • CRF completion guidelines
  • CRF annotation & review
  • Database build & design
  • Data validation specifications
  • Edit checks, programming & testing
  • Data processing through double data entry