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.

Meet the Data Management team:

Data Management Consultant
Frank Andreasen

Senior Data Manager with more than 17 years of experience within the pharmaceutical industry.  Clinical Data Manager experience encompasses; CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, user acceptance test, system validation, standard procedures, laboratory data, data import/export, coding procedures, CDISC SDTM standards, risk-based monitoring and data management oversight.

Data Management Consultant
Jens Sørensen

Clinical Data Manager with pharmacy background and 18 years of experience from the pharmaceutical industry. Experience as both insourced and outsourced consultant with all aspects of clinical data management including; CRF/eCRF design, database design, data entry, data 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.

Data Management Consultant
Faiyaz Hussein

Is a Data Manager with 15 years of Clinical Research experience with respect to Project Management, Data management, eCRF and database designing, validation of IT systems, integration testing, reporting on varied EDC systems, electronic patient reported outcomes ePRO, edevices in diabetes care (Insulin pumps, CGM) and submission to Health Authorities with major pharmaceuticals.

21 CFR Part 11, GCP, Six Sigma Green, BASE SAS, Inform, Medidata Rave, Clintrial 4.4 EDC’s and OC/RDC
Data Management Consultant
Evangelos Kapris

Experienced Clinical Data Manager with experience within: CRF/eCRF design, database design, data entry, data validation, query handling, protocol deviations, SAE reconciliation, quality control, data import/export, SQL programming, data migration, CDISC SDTM standards, MedDRA/WHODrug coding, risk-based monitoring and data management oversight.

M.Sc. Data Mining