edi software for clinical drugs trials  

21 cfr part 11 fda compliant concerning pre-clinical drug safety

   
  
 
 

edi software for clinical drugs trials clinical laboratory software

clinical laboratory software 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 software are of paramount importance for an efficient, client-orientated service.

Using the clinical laboratory software known as ClinAxys II the status of outstanding work for each department - biochemistry, haematology or urinalysis for instance - can be displayed at any time. For each test requested, the system knows whether it has been entered, worklisted, or if a result has been entered or reported.

Data consistency checks are applied during sample reception and any problems can be sent to a 'Helpdesk' printer for action. A final report cannot be printed until all inconsistencies have been resolved. The 'Helpdesk' will also be informed if any analytical results exceed a defined study-related range. These alert messages are designed to prompt further action, for example a phone call to the investigator.

Dual entry of subject demographics is a client-definable parameter that allows for checking of originally entered data. Dual entry of manual results is also client-definable with the ability to prevent the same operator performing the second manual results entry on the same test.

The audit trial is a vital requirement for all clinical laboratory software, especially in a multi-disciplinary environment. Where reporting is required in many different formats, the system permits data to be transmitted directly to the sponsor in a user-defined Electronic Data Interchange format (i.e. edi software). The reports design facility enables the user to produce both individual and cumulative clinical reports to the sponsors' numerous formats.

Cost-reporting and workload statistics, can be accumulated over time so that monthly and annual totals of work completed can be reported.

clinical laboratory software

 
 

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