ClinAxys^® II for Clinical Drug Trials

• In a clinical pathology laboratory handling drug trials, samples can arrive at any time from anywhere in the world. Therefore flexibility, fast turnaround, sample tracking and the ability to report data via EDI (Electronic Data Interchange) software are of paramount importance for an efficient, client-orientated service.
• The ClinAxys^® II laboratory information management system is designed to minimise the time spent assembling and despatching sample collection kits. Using a pre-determined bill of materials, kits can be defined and assembled as determined by the requirements of the study protocol. Subsequently, they can be despatched to the registered investigators as planned by the protocol and the despatch recorded.
• During sample reception, the samples received from each investigator can be checked against the study protocol and the sampling kit content. The data consistency checks applied during sample reception ensure that any problems, such as missing, unplanned or damaged samples can be referred to a 'Helpdesk' for action and printed. A final authorised report cannot be printed until all inconsistencies have been resolved. The 'Helpdesk' will also be informed if any analytical results fall outside of a defined, study-related range. The automatic alert messages are designed to prompt further action, for example a phone call to the investigator.
• 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 a specially formatted report.
• Using ClinAxys^® II, the status of outstanding work for each department - for example, biochemistry, haematology or urinalysis - can be displayed at any time. For each test requested, via a study protocol or individually, the system indicates whether it has been entered, work-listed, or if a result has been recorded or reported.
• Dual entry of subject demographics is a customer definable parameter that allows for checking of original data. Dual entry of manual test results is also customer-definable with the ability to prevent the same operator performing the second manual results entry on the same test.
• Before and after analysis, samples will be placed and tracked in frozen storage. The freezer management module identifies available storage space on a study basis, records all movements of samples, and maintains an audit trail of actions.
• The audit trail is a vital requirement for all clinical laboratory software, especially in a multi-disciplinary environment.
• Where reporting is required in many different formats, the reports design facility enables the user to produce both individual and cumulative clinical reports in the sponsors' numerous formats. Reports may be printed, faxed, or emailed. The system also permits data to be transmitted directly to the sponsor in a user-defined, Electronic Data Interchange format.
• Cost-reporting and workload statistics can be accumulated over time so that monthly and annual totals of work completed can be reported and used for billing if required.