ClinAxys® for Clinical Drug Trials Management
ClinAxys® provides integrated, protocol-driven facilities for the management of Clinical Trials including:
- Global operations for multiple labs, time zones, units of measurement, inventory and freezer locations
- Establishment of study-specific data (e.g. reference ranges, alert flags, reflex rules)
- Set up planned sampling visits including blinding and interim reporting
- Kit inventory, dispatch and quality control
- Independent labelling at the sample tube level ensures total operator control and auditability
- Fully audited Freezer Management with placement of samples controlled by study
- Import of spreadsheets containing any externally created tabular data
- Standard LIMS functions including bi-directional instrument connection and quality control
- Study Project Managers have overall view of their studies and control of operations in all locations
- Flexible client-based reporting by hardcopy, fax or email with conversion of units and languages depending on destination of report
- Restricted access for local users depending on their location
- Flexible reporting tools for access to the Oracle® database
- Special processing for PK/PD samples and reference laboratories
- Integration of other Laboratory Systems by HL7 and other protocols
- Workload and budget forecasting
- Performance Metrics.
- The assembly and dispatch of sample collection kits is a time consuming task which ClinAxys® is designed to minimise. Using a pre-determined bill of materials, bar-coded kits can be defined and assembled as determined by the requirements of the study protocol. Subsequently, they can be dispatched with requisition forms to the registered investigators as planned by the protocol and the dispatch recorded.
- 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 electronically report data are of paramount importance for an efficient, client-orientated service.
- 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®, 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 format (e.g. CDISC, HL7)
- Cost-reporting, forecasting, 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.