I just read an article about how researchers at Harvard Medical School are completely restructuring the genome of an E Coli bacteria to create an entirely new form of life. One of the most challenging parts of the research is getting it to be immune to all pathogens on earth; the second most challenging part of the research is filing in accordance with 21 CFR Part 11 regulations.

In order to ensure immunity to all pathogens it needs to be tested against each one individually and the results recorded and this needs to be done at least 400 times per pathogen in order to be statistically relevant. In order to do this amount of testing, Harvard is using automated testing methods plus the time of hundreds of grad students and technicians. These test results need to be verified and shared between trial teams and then stored in a repository where results can be found and checked by Harvard professionals as well as theoretically thousands of other laboratories worldwide. When and if this new genome has been created, it will be the first time that this type of creation has been successful.

The documentation for this trial will potentially be in the billions of pages. When I think of the ethical ramifications of this research I take pause; when I think of the documentation I feel at ease. If they turn to Adlib, as most large clinical trial facilities do, we will help them to automatically standardize all of their documentation, whether digital or paper, into high definition assets. We can help them capture all the data they need to organize and classify the content so that researchers can run queries and derive insight from the vast volumes of trial data. Plus streamline the FDA application process and ensure they meet all of their content compliance requirements. They eventually want to re-engineer human DNA. Not sure I feel comfortable with that idea but at least with Adlib their documentation would be secure. I will definitely keep my ears open to see where Harvard and others take this.