One of the common barriers to acceptance of EDC is cost. At face value paper trials cost you ink and paper and EDC a licence agreement – the price of which at first glance may seem a prohibitive or unnecessary expense. But is it? Because time is money. So let’s have a look at the time comparisons:
set up: if designed directly into an EDC there’s no reason why study set up should be slower than a paper design, infact with the ability to test and reports as you build, the design phase can be quicker.
data entry: a well designed EDC eCRF is as simple as simple as amy paper form to enter data on, and once it’s in, it’s in. Direct data capture on a mobile device adds to the simplicity – allowing clinicians to enter data whilst with a subject – whilst subject-led data capture removes the need for a formal visit entirely. There’s far less chance of data entry error in the first place with edit-checks, formatting and forumalae. There’s no need for time-consuming double-data entry.
queries and data management: Managing data queries is a very labour intensive aspect of clinical trials and a major source of delays. Manual tracking of paperwork adds significant time and cost to the study. On an EDC platform with notifications this is dramatically simplified and a significant area of time to market reduction. SDV is also hugely simplified and electronic signatures and automatic audit trails create a complete picture of who checked and amended what and when.
reporting: A paper trial still needs reports produced, so someone has to enter the data into a program for analysis. A well structured EDC platform provides numerous standard reports and a variety of customisable options. Outputs via excel, SAS and SDTM functionality create outputs to save time and money on statistical analysis and provide the compliance expectations of local regulatory bodies such as the FDA.
Add in the security and compliance risks and storage and access issues required for paper trials it becomes clear that an FDA compliant EDC system is no longer a nice to have, it’s a must have. The efficiencies are obvious, but on closer inspection so are the financial benefits. Even in international markets where labour costs are low, a sensibly priced quality EDC system will save you money while it saves you time.