Integrating EDC and Sample Management Solutions

Site staff find themselves having to keep track of collected and processed patient samples in paper sample logs or in self-created spreadsheets — but why? Likely because the sponsor will need to request information from the site to populate their own sample tracker in an attempt to follow the sample journey. Both manual processes rely on each other. This manual tracking continues when the CRA visits the site, as they check the site records and verify that the samples match their own tracker. This is in addition to double-checking against the clinical data in the EDC. This circle of manual redundancy is currently happening for every single sample. 

Now, let’s put some time parameters around the process. That same CRA is checking sample data against multiple sources (5 minutes). Inconsistencies are found and the CRA needs to review all documentation and speak with the site coordinator to understand what happened (15–30 minutes), then write and follow-up with the query (20–25 minutes). All in all, let’s assume it takes 45 minutes to an hour to validate just one data point. 

If any of you have been a CRA, you know that on top of so many other expectations, you typically have monitoring metrics to meet in terms of how many EDC pages are verified at each site visit, and not meeting these metrics could be problematic. Imagine if you have 120 pages to review per two-day visit, and you spend 15% of one day spinning your wheels figuring out one sample-related data point issue. It detracts from everything else that needs to be reviewed. 

Now if you are sitting in Data Management or Clinical Operations, you may not be sweating (too much) if your CRAs don’t verify all 120 pages in a visit. However, you are concerned about duplicative entry of sample data, the rising costs of source data verification (SDV), and that the data is clean and accurate. Not only do manual processes present room for human error, but when you are cobbling together several data sources — most of which may be manual — to ensure you understand the truth of what happened to your samples, it opens your study up to data quality concerns and overall risk to your programs, including the potential to prevent dose escalation. 

What if you could alleviate the headache of sample data reconciliation between the EDC and the myriad of manual spreadsheets, paper records, and emails? 

You can with Slope.

Removing Duplicative Data Entry Saves Time and Cost 

Imagine a scenario where a 21 CFR Part 11 system that maintained a 100% traceable chain of custody for your samples was integrated with your EDC. Duplicate data entry surrounding sample management could be eliminated. No more separate spreadsheets or trackers with multiple data points being captured several times at the site or sponsor to deal with.  

For the CRA, this is a massive time saver. For the sponsor as a whole, it reduces cost. How? You know that the data is the same in the EDC and in your sample management solution, but sites don’t need to enter it in both systems. Sample data likely still has to be source-verified, but at least it is not against multiple systems. With integration, sample verification could easily be worked into the sponsor’s risk-based monitoring planning. The fewer timepoints requiring SDV means CRAs are able to focus their time and energy on reviewing other critical data points, resulting in faster completion of patient review. The time saved could easily add up to fewer days on site and cost savings. 

From sample data reconciliation perspective, if sample data is recorded to the Slope platform via a barcode scanner at the site, and that data connects directly with clinical data in the EDC, the sponsor has assurance that the information will match without additional reconciliation efforts — including sample collection date & time, barcode identifiers, and even tracking information depending on the fields programmed.

The above example is just one use case on the power of integrations. Integrations streamline study execution — making sure that the right actions are taken, in the right systems, at the right time. 

Slope can easily integrate with any data system that has an API. We can trigger automations based on protocol-specific events or transactions to enable capabilities like synching Slope with patient visits from the EDC, etc. 

For more information on Slope’s approach to integrations, click here.