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ClinAxys® for Pre-Clinical Drug Safety

ClinAxys is the ideal system for Clinical Pathology Laboratories engaged in Pre-Clinical Drug Safety studies.

Unlike many LIMS systems for such studies, ClinAxys is highly customisable to meet sponsors' varying needs and allows for full laboratory sample tracking.

The benefits of the system include:

Comprehensiveness and Ease of Use

  • Entry and editing of study protocol information, individual subject details, dose groups and planned sampling events
  • Generation of sample tube labels
  • Registration of samples and recording of their condition
  • Assignment of unique laboratory numbers, with or without randomisation
  • Freezer Management within the pre-clinical and clinical facility
  • Allocation of samples to requested tests and generation of laboratory worklists
  • Acceptance of data from on-line instruments as well as data entered manually
  • Verification and validation of captured data
  • Calculation of derived parameters and reflex testing
  • Multi-compound analysis
  • Generating mean and standard deviation statistics
  • Provision of parametric and non-parametric statistics for dose groups in pre-clinical work.
  • Management of sample storage
  • Complete audit trail.

Reporting

  • Standard and definable reports
  • A special request entry and reporting function for PK/PD work, facilitating high-speed entry of requests for all time points and all subjects in the study
  • Electronic data transfer directly to sponsors in a variety of formats, if required.

Customisation

  • Totally configurable to reflect each laboratory’s operation and workload
  • User-definable study specific information e.g. reference ranges, reports, costs, etc.
  • Individual reports, formatted to the sponsor's needs, electronic data interchange (EDI) capabilities and statistical analysis.
ClinAxys has enabled us to rapidly and accurately meet our study sponsor’s agreed requirements, increasing the amount of repeat business we obtain.

Enhance sponsor interaction & satisfaction with ClinAxys®.

Oracle Partner NCC Group

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