Data Management

Our Data Management team has valuable experience working with global and domestic sponsors and renders well timed, accurate, highest standard clinical trial data, helping you to make prompt and more effective decisions with regards to the safety, tolerability and PK/PD properties of your compound.

The team has handled both paper and EDC on all standard industry platforms. Stats – IT Solutions consultants offers 21 CFR Part 11 compliant integrated service | stand-alone data management support on Oracle Clinical® v4.6 with RDC platform or remotely through a secure, direct-access connection to your clinical data management system.

Our services includes but not limited to:

  • Project Specific Clinical Data Management Plan
  • Customized Database Design & Development
  • Independent Double‐Data Entry
  • Design pCRF / eCRF
  • Develop CRF completion guidelines
  • Query Management
  • Medical Coding, SAE Data Reconciliation
  • Edit, Validation and Design check
  • Programming
  • Data Validation
  • Database Testing & UAT
  • Data Migration
  • Data Loading
  • Data Cleaning
  • Quality Control and Data Quality Audits
  • Database Lock and Export to SAS
  • Project Data Archival and Storage
  • Documentation CDM Report