Collecting Data for Pharmacokinetics Studies

Prelude Modules: Pharmacokinetics (PK)  

When running pharmacokinetics “PK” studies, efficiency and speed are essential in getting sample data recorded. Researchers evaluate how a drug moves through the body and the actions the body takes in relation to the drug’s presence over time. Prelude’s automated PK module is compatible with animal and human PK studies. It allows labs and sites to easily track data points for each sample collected, including dosing and time, per the study’s predetermined sample schedule, within Prelude’s electronic data capture (EDC) system. How does it work? 

Initial Configuration 

• Within Prelude EDC, specify the number of sample collection forms the study calls for.  
• Each form can be used to define different sample schedules – time points and a tolerance for each. Tolerance allows for an acceptable range of time during which the sample can be collected. 
• Pre-defined related fields for each sample, such as blood draw location, are easily added with a click. This versatile module also allows for customized fields, a convenient option for additional data collection. 

• If collecting samples from multiple subjects at once, we can accommodate that! More details below… 
• Simply drag and drop the module into the study’s PK related forms. When rendered, Prelude EDC will automatically display the PK module per the specified configured settings. 
• Any additional inputs, including the option to upload results, can easily be built into the form. 

Your study is live – up and running. What happens next?  

Data Collection 

• Dosing is tracked with the click of a button. Prelude EDC automatically marks the dosing date and time, as well as the expected time for each sample collection. It’s go time! 
• Each time a sample is marked as collected, Prelude EDC automatically marks the time and related data points, including whether the sample was collected within the specified range of tolerance. Any sample not collected (let’s say blood could not be drawn from a vein) requires a reason. 
• And if enabled for those collecting samples from multiple subjects at once, users can view the next subject up for collection and quickly flip to that next subject’s PK data collection form. 

Reports & Exports  

• And of course, as with all study data, PK data can be pulled into reports and exports.  

In conclusion, pharmacokinetics studies are crucial in evaluating how drugs are absorbed, distributed, metabolized, and excreted in the body. To conduct these studies efficiently and accurately, it is important to have a reliable and user-friendly system for recording sample data. Prelude EDC is that system – labs and sites can streamline their PK studies, saving time and improving the overall quality of their research.  

Want to run a PK study with Prelude? Ask us how to begin.