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ClinAxys® for Clinical Drug Trials Management

ClinAxys® provides integrated, protocol-driven facilities for the management of Clinical Trials.

It offers fully global capabilities, covering multiple labs, time zones, units of measurement, inventory, sample management and freezer locations - with fully-controlled access for authorised local users.

The benefits of the system include:

Comprehensiveness and Ease of Use

  • Integration of other Laboratory Systems by HL7 and other protocols
  • Comprehensive standard LIMS functions including bi-directional instrument connection and quality control
  • Import of spreadsheets containing any externally created tabular data
  • Total operator control and auditability via independent labelling at sample tube level
  • Establishment of study-specific data (e.g. reference ranges, alert flags, reflex rules)
  • Set up of planned sampling visits including blinding and interim reporting
  • Fast, efficient kit inventory, dispatch and quality control
  • Fully audited Freezer Management with placement of samples controlled by study, and full audit trail
  • Special processing for PK/PD samples and reference laboratories.

Quality, Security & Reporting

  • Restricted access for local users depending on their location, plus full user audit trail
  • Overall view of studies and full control of operations in all locations for Study Project Managers
  • Data consistency checks to identify missing, unplanned or damaged samples received from each investigator, or if any analytical results fall outside of the study protocol range
  • Dual entry of subject demographics and of manual test results to prevent the same operator performing the second manual results entry on the same test
  • Record for each study protocol or individual test requested, showing if entered/work-listed/and result recorded or reported
  • Flexible reporting tools for access to the Oracle® database
  • Clinical reports design in multiple formats, both individual and cumulative
  • Flexible client-based reporting by hardcopy, fax, email and electronic format (e.g. CDISC, HL7) with conversion of units and languages
  • Performance Metrics
  • Status of outstanding work by department e.g. biochemistry, haematology, urinalysis, serology, immunology
  • Cost-reporting, budget forecasting, and workload statistics for billing.
The ClinAxys® module for Clinical Drug Trials Management has enabled our clinical pathology lab to make a huge leap in how efficiently we deliver client services. Regardless of when samples arrive, or from where, we can now offer much faster turnaround, sample tracking and reporting.

Ensure oversight, transparency, compliance and accuracy with ClinAxys®.

Oracle Partner NCC Group

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