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Clinical Data Management Services

  • Intelligent data capture backed by the experience of running some 800 phase I - IV clinical trials

  • Streamlined / optimized data management processes characterized by higher quality coming at lower cost

  • Continuous data review and trending to identify and correct logical errors

  • Preventing mechanical errors or containing error sources with the Automated Navigator, double data entry and and VVE (Valid Value Edits)

  • Build study protocol into the iEDC data entry application that will guide clinical personnel into capturing clean data

  • Set up new clinical trial studies sql server database systems, testing and validation

  • Safety review and 100% cleaning of primary endpoints variables

  • Quality assurance - determination of error rate, and generating the FDA required Quality Certificate

  • Coordination with Central laboratories

  • Incorporation of Electronic Data e.g. laboratory results

  • Electronic database transfer e.g. ASCII, SAS® datasets (9.1) and/or transport files

  • Generating the double Electronic audit trail (field and form level)

  • Dictionary implementation and maintenance

  • Medical coding of adverse events (AEs), diseases and medication using MedDRA, WHO DRL / ATC or Sponsor specific thesauri

  • Automated AE & SAE Reconciliation

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