Clinical trials — a case for reform

Mike — Thanks for taking the time to comment on the article. Some valid points, some not.

We are not actively selling anything. All we are suggesting is that there is a better way to run a clinical trial. Accepting that the current process is fine is just cruel and unacceptable. We are not fixing the process — we are starting from a blank slate and imagining how a clinical trial should be run, in 2016.

Currently, as you know, there are series of plug-in solutions that are assembled by pharma’s/CROs to run clinical trials. Just a cursory look at the process should inform you that this is inefficient and obsolete. We are suggesting a change in mindset/process.

You do not need these obsolete processes (SDV/data cleaning/on-site monitoring — all these processes fix things that were done wrong in the first place) or endless backups (paper with more paper backups!) just to prove that your drug works. You should conduct your trial once and do it well. That means collect data at source, store it in cloud and perform real-time analytics — it is not rocket science (though some of it is!). We are substituting people with technology, this streamlined process saves time and money.

Unfortunately, the status quo is just too lucrative for incumbents to give it up.

Besides selling eclinical software, our larger mission and the reason why we exist, is to get more drugs to the market and do it at a lower cost.

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