High-quality clinical data is critical to regulatory success. We help sponsors and CROs capture, clean, and prepare clinical trial data in compliance with CDISC, 21 CFR Part 11, and GCP standards.

Service Coverage:

Study Startup & CRF Design

Protocol review, CRF/eCRF design, database specification development

Validation plan creation and user acceptance testing (UAT)

Platforms: Medidata Rave, Oracle Clinical, Inform, Veeva CDMS, Clario, REDCap

Data Collection, Cleaning & Validation

Real-time query resolution, discrepancy tracking, site communication

AE/SAE reconciliation, medical coding with MedDRA & WHO Drug

Mid-study updates with minimal downtime

Standards & Regulatory Readiness

Full CDISC conversion (SDTM & ADaM datasets) for regulatory submissions

Annotated CRFs, define.xml, reviewer’s guides, and data traceability matrices

Audit trail generation, archiving, and readiness for FDA 483 inspections