ClinAxys® II for Pre-Clinical Drug Safety
ClinAxys® II is the ideal clinical trials management system (CTMS) for clinical pathology laboratories engaged in Pre-Clinical Drug Safety studies. These studies operate in a very systematic, controlled and planned environment, requiring tests and reports on large groups of subjects.
Contract research establishments are increasingly finding that the inflexible data definitions used in many LIMS (Laboratory Information Management Systems) for pre-clinical Drug Safety studies do not cover their sponsors' varying needs or allow for laboratory sample tracking.
ClinAxys® II has been designed to allow customers to set up study specific information such as reference ranges, reports, costs, etc., enabling them to provide an individual service to each sponsor. Alongside this personalised service comes the ability to produce individual reports, formatted to the sponsor's needs, electronic data interchange (EDI) capabilities and statistical analysis.
ClinAxys® II can be configured to reflect each laboratory’s operation and workload to provide the following facilities for pre-clinical drug safety studies:-
- Entry and editing of study protocol information, individual subject details, dose groups and planned sampling events
- Generation of sample request forms and 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 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
- Standard and definable reports
- EDI data transfer directly to sponsors if required
- Management of sample storage
- Complete audit trail.
- A special request entry and reporting function is available for PK/PD work and facilitates high-speed entry of requests for all time points and all subjects in the study.
