AICROS and EDC systems

AICROS and EDC systems

We are living in a transition period in relation to the data collection for clinical trials. The trend is that paper-based data collection is replaced more and more by Electronic Data Capture (EDC).

In this article we will point out the advantages of EDC and what to take into account when selecting an EDC system.


EDC systems growth

According to Thomas Kirssner, an expert on data management, using an electronic data capture system is similar to online banking.

Not that long ago, it was normal to spend the whole morning queueing at your bank office, and without smartphones to keep us entertained!

Nowadays, most bank transactions can be completed directly from your smartphone in only minutes. It was scary at the beginning and most people were reluctant to do it, but more and more we are now trusting online banking.

The same can be said for EDC systems, we are getting used to them but there is still a long way to go.

Proof of this is that there is still around 25% of paper based CRFs and many people have reservations with regard to the electronic model.


eCRF versus Paper CRF


When comparing paper based CRF with eCRF, the differences are huge:

Paper CRFs have a lower learning curve, however, they require more investment in the data treatment and monitoring.

eCRFs have a higher learning curve and also a higher investment when starting a clinical study (mainly licenses and training), however in the mid and long term, they save time and money as a result of the improved of data quality.

Another advantage is that the slope of the curve is decreasing as EDC systems are becoming more competitive and investigators are becoming more used to them, so the learning time is also reduced.


PM Considerations for NDA/MAA Submissions



Types of EDC systems

There are some basic features that all EDC systems have: data storage, open patient records and audit trails.

EDC systems also add value by:

  • Offering the ability to remotely review and clean data.
  • Enabling the identification of risk such as serious adverse events to the project manager or to any other party involved.
  • Having a system that can interconnect all the different electronic data sources: eCRF, electronic randomization tools, drug supply management, central labs and ePRO (usually data is stored separately and is unified manually with the risk that data errors can be caused by manual data handling).



How to choose an EDC system


Your EDC system should serve you. If you need to take care of it, you should probably change it.

As there is a wide range of prices for EDC systems, the first thing you should do is evaluate what you need at a trial level and the allocated budget.

Next, list what do you expect and see what systems can provide your needs. After that, you just select a reliable service provider as a partner.

And remember, the goal is to conduct the study the best way possible, not to have the best EDC system.


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