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Services | Biometrics | Data Management

ORION’s dedicated team of Data Managers, Data Coordinators and Data Entry staff work in close collaboration with the Clinical Research, Project Management and Pharmacovigilance teams. They work either to our own in-house procedures or the client’s SOPs, in full conformity with ICH.

Our internal Quality Assurance Department regularly audits the Biometrics Department in the context of both System and Project related audits.

Our services include:

  • Database design and validation
  • Dictionary set-up and coding
  • Programming of edit checks
  • Development of query resolution conventions
  • Independent double data entry and reporting
  • QC of database and database lock
  • Blind review and reporting including ongoing safety table generation if required
 
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