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.
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