• CRF Design / eCRF
  • CRF Completion Guidelines as per CDISC standards.
  • Data Management Plan (DMP)
  • Data Validation Plan (DVP)
  • Checks Specification and Programming
  • Testing Database Design
  • Patient/CRF Tracking, Entry, and Verification

Data Entry

  • Double Data Entry, Automated Double Data Comparison and Synchronization.
  • Handling External Data (Data Import/Export)
  • Medical Coding (MedDRA, WHO-Drug, WHOART, COSTART or Sponsor-developed).
  • Integration and Verification of External Electronic Data.

Quality Control

  • Remote Data Access.
  • Identification and Tracking of Protocol Violators
  • Electronic and Manual Discrepancy Identification and Automated Data Queries (ADQ) Generation.
  • AE/SAE Reconciliation and Reporting.
  • Accelerated Database Lock