Clinical Data Management

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.

[wpv-view name="blog-author" users="4"]

Data Management

Pharma IT is expanding

We are proud to announce that Pharma IT has included Data Management in our growing range of services to the pharmaceutical industry with the addition of Jens Sørensen

Jens has more than 18 years experience from the pharmaceutical industry working in Data Management as both insourced and outsourced consultant with all aspects of clinical data management including; eCRF and database design, data entry and validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SAS and SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk based monitoring and data management oversight.

In Pharma IT we believe that we can improve the standards of pharma consulting – should you have any questions to our Data Management services please let us know.

Pharma IT consists of highly experienced people as well as young talents and we invite you to take a closer look at our Team

[wpv-view name="blog-author" users="4"]