Pharma IT can support you with 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
These services are currently available via our partners and our extensive freelance consultant database.
If you need support don’t hesitate to contact us.