The Future of Data Integrity

Using Blockchains & IoT to Record Clinical Trial Data

August 29, 2018


Cryptowerk partners with InnoME and essentim to deliver a blockchain and IoT based data acquisition solution for clinical trials

When managing research data for the purposes of clinical trials, it is imperative to be able to prove collected data integrity, provenance and security. Organizations involved in clinical trials are under increasing pressure to digitize their products, processes and business models to remain competitive and to meet increasingly stringent regulatory and industry compliance requirements. At the same time, they must balance the complex logistics of data gathering, data security and more.

To address these challenges, research organizations are increasingly turning to state of the art IoT based sensor technology and distributed ledger technologies (blockchains) that can be used to verify the provenance of research data, and to verify that research data, consent forms, and other information has not been tampered with, providing enhanced security and transparency. These distributed technologies can be vital in proving data provenance, data integrity, and data security.

Cryptowerk is partnering with InnoME and essentim to deliver a combined solution of sensor hardware and embedded cryptography that delivers data from the PoI and blockchains, creating  an unalterable, tamper-evident data set for all important steps throughout the research process.

InnoME provides a unique combination of know-how in low cost and low power sensors, wireless technologies, and scalable production capabilities. essentim provides an IoT-based sensor solution tailored to the needs of process monitoring and documentation in the biomedical space. Together with Cryptowerk’s blockchain-based data integrity software, the combined solution offers many of the key capabilities needed to achieve digital transformation goals, including:

  • Measurement equipment (e.g. consumables) enhanced with sensor technology to deliver raw data that directly relates point of interest.
  • Securely seal raw clinical trial data such as data from IoT systems and other automated collection. Data can be sealed in the blockchain at the moment of generation and later automatically compared to the data being entered into “official” logs to confirm it hasn’t changed.
  • Detect manipulation of By fingerprinting original consents, research reports and other datasets, and putting those seals into a blockchain, anyone can later test that the dataset has remained unaltered by verifying it against the blockchain fingerprint. An organization can then easily prove the original dataset has not been tampered with.
  • Track pharmaceuticals used in clinical trials in compliance with DSCSA and other regulations.
  • Instantly verify the identity, experience, and training of clinical research personnel— even when those personnel change companies.

The combined solution offered by InnoME, essentim and Cryptowerk makes IoT data acquisition and blockchain-based digital notarization frictionless. It is designed to reduce risk and lower costs of instrumenting your existing applications with distributed ledger technologies. Benefits of this solution include:

  • Scalability: The patent-pending technology allows Cryptowerk to accelerate writing to public blockchains up to 600,000 transactions per second.
  • Affordability: Reusable sensors and sensors integrated in consumables allow faster, more inexpensive time- to-instrumentation without interrupting operations. Transaction costs for public blockchains are much lower and predictable due to Cryptowerk’s approach. No blockchain programming experience is required to add the benefits of distributed ledgers to your applications.
  • Interoperability: Unlike most solutions, this solution is 100% environment-agnostic. This allows companies to select an approach without risking everything on a single hardware or software
  • Reduced risk: System integrators can immediately take advantage of well-documented APIs without having to reprogram existing
  • Data Privacy: No sensitive data is transferred to the technology providers—only digital fingerprints

For more information download the white paper here.