Q: Why do you think BlockChain can work in this area?
A: BlockChain technology permits a peer to peer mechanism for immutably recording and preserving data that cannot be knowingly tampered with in a speedy and secure manner. Our POC has validated the concept.
Q: Why is Bloqcube™ unique and innovative?
A: Compared to those not using BlockChain, we believe that the speed, security and cost savings of our approach is going to be potentially unparalleled. In addition, we plan to leverage the benefits of smart contracts to address issues in Clinical Trials and potentially provide an end to end solution with C2TA ®- Continuous Clinical Trial Accounting
Q: How does our approach optimize clinical trials process?
A: In our POC, we developed an oncology mock-up trial on 5 patients from end to end. We simulated the three key groups- patients/physicians + Sponsors + Data Safety Management boards/auditors
Q: What is the difference between Public and Private?
A: We are evaluating the differences between public vs. private and permissioned blockchains for ensuring patient data privacy while having the ability to share, audit, and append an immutable single data source. We are choosing a permissioned blockchain for HIPAA and size considerations; we demonstrated that successfully in our POC.
Q: What is the difference between blockchain and centralized databases as it relates to security and data-sharing capabilities?
A: Cryptography, distributed capabilities, immutability, fraud prevention etc. Fraud is not an unknown in trials and has led to major fines by regulatory agencies on some pharma companies in the world.
Q: What are some of the regulatory considerations when employing a blockchain solution?
A: 21CFR Part 11 compliance, risk-based approach for verification, validation, and testing in full compliance with FDA and other regulatory guidance