Over the last two years Guardtime has been investigating what does blockchain actually mean in terms of real, valuable solutions for the industry that can be applied today.
Let’s start with Data Integrity – the
most basic requirement for any clinical trial – accurate and reliable data
throughout its life-cycle.
The FDA defines that “data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)."
If you ask a Life Sciences expert about how they achieve ALCOA the answer will invariably be “We have processes in place to achieve ALCOA run by trusted insiders. We also conduct regular audits run by accredited external auditors”.
This of course is expensive, unreliable, unverifiable and ultimately based on human trust. And therein lies the opportunity for blockchain – replace human trust with mathematical certainty. Digitize, automate and make processes immutable.Data Integrity is just the start - the real opportunity for blockchain in clinical trials is process integrity. Data doesn't exist in a vacuum - how did the data come to be and was the process carried out in accordance with pre-agreed rules. Over the last two years we have learned that process inefficiency in the marine insurance industry is as high as 40%. What is that number in clinical trials and how much can it be reduced ?
For this and much more please join Glen at BIONJ 2018: https://bit.ly/2M6b4ZC