Myths and Reality Of EDCS In Clinical Data Management
Today in this blog topic we would discuss EDCS and its utility in CDM i.e. Clinical Data Management. EDCS is the acronym for Electronic data capture System.
EDC is very common in usage in clinical study yet there are so many myths and misconceptions surrounding the move from conventional, paper-based clinical data input to EDC. The only fact is that EDC technology more the cloud-based systems are comparatively a recent addition to the clinical research industry.
Though EDC is no longer a novel object, yet it is too young to be embraced as the next industry standard. EDC is caught somewhere in between.
Here we discuss the myths surrounding with it and how to overcome them.
Myth 1: EDC is expensive
Reality: EDC cuts down study costs
Some EDCS are pricey to install, train the staff and implement, but the overall budget during the study and after the study cannot be underlined. Sponsor ROI for switching to EDC is well worth the initial investment.
The very thought that EDC is expensive is a remnant of the early history of EDC. When the technology was first initiated, as with any first generation thing, the more capable the system was the more expensive it was. EDC vendors are now available, all competing to overtake in performance the other guys and that too in the most attractive price point.
Myth 2: Switching to EDC involves too much time
Reality: EDC is very precious to study time
This myth has been true when EDC got first rolled out for clinical trials, but it is entirely a baseless argument today. To mention, 80% of the time and money spent on pharma development is spent on repetitively conducting clinical trials. For your information, EDC allows both for an attractive cost ROI and time ROI too.
On an average, EDC cuts 41% of pre-study preparation time.
Myth 3: Data stored in the cloud is unsafe
Reality: Cloud storage is comparatively more secure than on-site and/or paper
We all know and heard about the urban style of cyber theft. We hear horror stories of identity theft, hacking of bank accounts, etc. Always an exception exists for the rule; data storage for the most of of cloud systems is protected with huge and redundant security protocols against loss, theft or corruption of integrity.
Myth 4: EDC is meant for massive Phase III+ studies
Reality: Studies of every size can take advantage of EDC
Though the origin or initiation of EDC was done keeping larger studies in mind like phase 3 clinical trials or later, but currently there are systems present to match every varying degree of study be it simple ones or complex. Of course, the longer the duration and greater the number of variables measured will explain the actual value of switching to EDC.
To mention EDC systems are very much customizable. If your next clinical venture is going to have more or less data than the previous study, your EDC vendor can work with you to customize the system as per requirement, so your team does not need to spend time and effort to source another vendor.
What are the possible disadvantages of EDC for CDM?
To be honest, there is not a single scenario where EDC does not defeat or is a better choice than paper-based data management in terms of savings of time and money. EDC is even “green” compared to conventional data capture methods.
Please let us know your opinion and views on EDC and its usage in CDM in the comment section below.
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