PK Reconciliation

Pharmacokinetic (PK) Reconciliation & sample tracking management tool. Intuitive and streamlined setup process by study teams...                                                                   

Our latest tool for the clinical trials arena is our PK (pharmacokinetic) reconciliation tool. It reconciles 100% dosing vs. PK sampling times, with no double-data review between review cycles. The user dynamically interacts with the tool’s interface as it automatically highlights potential discrepant data, bringing both automation and quality to this niche area of the clinical trial community. An ideal tool for study teams for regular PK checks or for PK oversight control. This tool will shortly become available commercially and will be an off-the-shelf solution through a licence agreement.

 

 

 

 

Features:

  • Setup requires no programming

  • Flexible data sources (e.g. raw EDC and lab files or SDTM)

  • Adjustable review mode allowing users to add/remove columns as per personal preference

  • Easy to understand discrepant data issues

  • Apply data cuts by date or visit - ideal for upcoming deliverables!

  • Reporting options

  • Actions are stored for future review cycles (i.e. the user will not have to re-review data that has not changed)

  • Creation of a permanent issues list that can be managed within the tool - ideal for your PK scientist or statistician

  • Status metrics / site performance KPIs

  • No need for multiple tracking sheets!

  • No more manual review with multiple open spreadsheets - save hundreds of hours per study team!

 

 

 

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info@apples-and-oranges.co.uk

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