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Shortcomings of EDC
The industry has been discussing the introduction of EDC into trial workflow for 15 years. Despite this, most trials carried out worldwide are still paper-based. This conservatism has to do with the shortcomings of EDC: high investment thresholds for online data entry hardware and software, high investigator learning curve, and not least the fact that EDC trials have proven to create an environment that inhibits intimate interviewing of the patient. It is difficult to communicate when there is a screen between the investigator and the patient. Thus, the central tool for EDC is also the central impediment to broad acceptance.
Of course, we do not deny certain benefits of EDC such as online plausibility checks. But we also see the long time frame needed for the preparation and design of databases, the necessary investment in hard- and software, technical problems and last but not least a certain aversion of investigators to act as data capture personnel.
PharmaForms introduces a perfect synthesis of the benefits of both, paper and electronic means. We have called it dotforms™.
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