Clinical Data Management

Pharma IT offer Clinical Data Management consulting services to support clinical trial data during early drug development and post market clinical commitments.

  • Protocol Development
  • Paper/eCRF and database design
  • Data Management Platform (DMP) Development
  • Database Testing & User Acceptance Test
  • Data entry and validation
  • Discrepancy Management
  • Clinical data surveillance
  • Protocol deviations review
  • Serious Adverse Event (SAE) reconciliation
  • External and third party data reconciliation
  • Quality control
  • Database Lock & Freeze
  • ePRO, eCOA and device data integration
  • SAS and SQL programming
  • Data mining and migration
  • CDISC SDTM standards
  • MedDRA/WHODrug coding
  • Risk based monitoring
  • TMF Support & Documentation
  • Submission and DM representation in inspections and audits
  • Vendor management
  • Project management and Data management oversight

Our services can be delivered by our own team or via off-shore partners.

If you need support don’t hesitate to contact us.