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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®.

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