Ana Castilho

iUZ Blog | EDC

 

Wondering what EDC means?

And Clinical Studies?

Here at iUZ we’ve been working with our uEDC solution that focuses on Clinical and Observational Studies.

 

Electronic Data Capture

EDC, the acronym for Electronic Data Capture, is an electronic medical record system specialised in clinical research, with the main objective to collect clinical data in an electronic data.

With the increase of Information Technology (IT) in healthcare, is not new that there is a trend and a need to a simpler, effective and highly specialised electronic data capture systems that can be easily implemented and customisable, always thinking in the end-user.

EDC systems are web-based software platforms that are created to collect and store clinical data through electronic forms, and usually the user only needs a web browser.

Typically, electronic source data is used for health clinical investigations, where sponsors and CROs (Clinical Research Organisation) use this type of systems.

 

We tend to sort out these 3 EDC system types:

  • Clinical trials: Applied during the phase of a medicine with pre-market entry, with an advanced certification demanding;
  • Clinical studies: Applied during the entry phase of a medicine on the market;
  • Observational study: A non-interventional study, mostly applied during a medical treatment.

Usually EDC systems are designed to demonstrate the efficacy and/or safety of medical treatments or medicines.

 

Main features

At iUZ we’ve been upgrading our uEDC solution.

A platform targeted for clinical and observational studies offering advanced features, with an easy customised setup to specific study requirements. For activating a new Clinical Study it is required a CRF (Case Report Form) and a DVP (Data Validation Plan) along with the platform setup. The CRF is a paper or electronic questionnaire used in clinical research, which the study promotor develops containing all the questions that the study will have.

In this competitive healthcare market there are several Electronic Data Capture solutions, but obviously not all of them have the same features.

iUZ uEDC solution has the following main features (view also our Standard Feature List flyer):

  • Clinical Study Setup
  • Profile and user management
  • Data entry
  • Data validation
  • Data management
  • Calibration
  • Data export
  • Notifications
  • Audit Trail

 

The main benefits of Electronic Data Capture systems are:

  • Higher security
  • Faster and efficient, compared with paper-based systems
  • Reduces data entry errors, which are also detected earlier than with paper-based systems
  • Accelerates the clinical data management process
  • Decreases clinical development costs
  • Higher time-savings
  • Major tendency to the fulfilment with regulatory requirements
  • Data is centralised in a specific electronic database
  • Real-time view of the data collected

     

 

Want to see our solution? Ask us for a uEDC live demonstration. In the meantime, view our uEDC video.

 

Did we forget about some important aspect? Have some doubts? Please, let us know in the comments.

 (image from Flickr by Myfuture.com)

Opening the Future of Healthcare.
Contact iUZ today at +351 234 247 381 or visit iuz.pt

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