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Clinical trials are a multi-billion dollar industry. One of the biggest challenges facing the clinical trial research community is satisfying Part 11 of Title 21 of the Code of Federal Regulations and ISO 27789. These controls provide audit requirements that guarantee the reliability of the data contained in the electronic records. Context-aware smart devices and wearable IoT devices have become increasingly common in clinical trials. Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS) do not currently address the new challenges introduced using these devices. The healthcare digital threat landscape is continually evolving, and the prevalence of sensor fusion and wearable devices compounds the growing attack surface. We propose Scrybe, a permissioned blockchain, to store proof of clinical trial data provenance. We illustrate how Scrybe addresses each control and the limitations of the Ethereum-based blockchains. Finally, we provide a proof-of-concept integration with REDCap to show tamper resistance.
This paper presents a spatial encryption technique for secured transmission of data in networks. The algorithm is designed to break the ciphered data packets into multiple data which are to be packaged into a spatial template. A secure and efficient
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FDA has been promoting enrollment practices that could enhance the diversity of clinical trial populations, through broadening eligibility criteria. However, how to broaden eligibility remains a significant challenge. We propose an AI approach to Coh
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Clinical trials predicate subject eligibility on a diversity of criteria ranging from patient demographics to food allergies. Trials post their requirements as semantically complex, unstructured free-text. Formalizing trial criteria to a computer-int