Importance and Benefits of Open Source Clinical Trials

Today, many highly successful contract research organisations (CROs) complete clinical trials using Electronic Data Capture (EDC). Many software companies – like OpenClinica or Artiezio – considerably speed up and optimize medical product development. These systems have been designed to make it easier and quicker to start up a clinical trial, help to reduce how long a trial lasts and help to avoid data errors. When comparing EDC systems to traditional forms of data capture, using paper records and entering these into a database, it quickly becomes clear how much easier and more accurate EDC is. It ensures data can be recorded into the system immediately, using software available on portable devices, rather than having to write it down and transcribe it later.

Clearly, EDC is a tool that can be used to completely avoid data transcriptions and the errors that are common with this. It is possible to immediately apply validation and edict check, thereby reducing the chance of errors even further. With paper based processes, it often takes several months to get to this point.

What Is EDC?

open-source-clicnical-trialsAn EDC is a platform that is web based and often fully open source. It allows for the management of multi-site and single clinical research studies alike. It also allows for configuration of protocol, clinical data management, data extraction and the design of electronic Case Report Forms (eCRF).

There are a number of examples of open source EDCs and they all meet the regulatory guidelines for clinical trials. This is something that concerns users, who worry that open source means that anyone can access the data and make changes to the system. In reality, however, the EDC is an extensible system that is highly robust and, above all, secure, allowing for various clinical research studies to be managed from a central point.

In fact, using an open source EDC means that there are many more methods for data retrieval and query across a range of clinical parameters. Additionally, it allows data to be exported into a variety of different file formats that are used within clinical research. All of them include data monitoring, validation and input. When data is inputted, the EDC will automatically validate it, thereby avoiding entering data that goes outside of admissible values. Additionally, they have been created using standards as determined by the U.S. Health Department. Additionally, validation is fully compliant with FDA process requirements, Good Clinical Practice (GCP) and various internal standard operating procedures. As such, it is clearly the best system out there.

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About Ferland Manuel

Dr, Manuel Ferland is health care specialist,