Business Background
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The reasons EDC was born
RDE (Remote Data Entry) appeared in order to reduce the number of mistakes made in writing on paper CRF. A special software was installed into PCs and, after data entry, modem lines were used to transmit the data. This EDC systems did not become popular because laptop PCs were still expensive at that time and operation was complicated.
A long with the popularization of internet, web-based software become available and then FDA adjusted the regulations on electronic data collection and signatures, so that FDA 21 CRF Port 11 came into effect.
FDA Part 11, however restrics the use of computerized technology more than necessary, and does not match the original intent, besides, the costs required to conform to the regulations become higher than initially anticipated. With these reasons the regulations were clarified narrowly to interpret or withdrawn, and thus EDC was promoted to spread in the USA. Influenced by these trends, EDC utilization rate has been increasing in Japan too.
The merits of EDC
Merits for clinical trial sponsors
- Laborsaving in CRF collection by monitors and post-collection input work
- Greater efficiency of clinical trial work (contraction of development period, reduction in total cost)
- Improvement in the quality of clinical trials by data cleaning at the time of input
- Blinded reviews are possible
- Real-time status management (visible prior to acquisition of CRF)
Merits for medical institutions
- Prevention of protocol deviation
- Securement of quality at the time of CRF creation
- Reduction in waiting time at the time of registering caseo
EDC's Current State and Issue
- Infrastructure development such as internet, etc. has not yet spreaded as far as small-scale medical institutions
- There are multiple types of EDC, and their operation methods are different depending on the developer
- Changes in CRF and databases are difficult after the start of a clinical trial (careful planning is required in advance)
- Legislative response is left to the judgment of the sponsor (ER/ES, etc.)
Background to the Development of "ARCS+"
"ARCS+" is an acronym of "ACRONET Remote data Capture System Plus (+)." We started developing this system in 2001 and have been accumulating its usage results steadily. We packaged a lot of know-how into the system and made a number of function improvements such as PHS for bad communication environment situations,so that started selling "ARCS+" in 2003.
In addition, in 2006, ACRONET started selling of "ARCS+ PMS," a specialized system for use in post-marketing surveys. A variety of functional expansions and operational configurations are possible with in-house adaptation. We also provide "ARCS+ ENTRY," a system created by cutting out only the case registration and progress management functions from "ARCS+", at low-cost in areas from clinical research to post-marketing surveys.
