and you need to stop guessing.
I honestly don’t know where or how to start this post.
I have more questions than answers.
It all started almost a year ago with an idea to create an API service that takes data from clinical trials and automate anomaly detection.
The what (“Anomaly detection of structured high-dimensional time-series data”) was clear. Build an online service to detect anomalies in clinical data; send a JSON structure and we’ll tell you what data samples are suspicious.
The why and who was also clear — help democratize clinical data anomaly detection and make devices and drugs safer, more effective, and accessible for patients and physicians by eliminating bureaucratic and organizational constructs that stand between the patient and investigator and the truth.
But the how — was something else entirely.
How do you do this?
There is a lot of clinical data out there — most of it outside your doctor’s office
The first question is volume.
The world of real-world clinical data is exploding. The variety, volume, and velocity of this type of data are growing exponentially. Our clinical data is being generated all the time, by multiple sources at varying times. The result is an endless body of data, unsynchronized in place, time, and doctor visits.
Can we rely on this data to make decisions? Can we quantify the risk?
The second question is how to quantify risk?
Is there a more relevant question for a $1.5 Trillion/year life science industry and a world where over a million people have died from SARS-COV-2 and FDA is tightening guidance on safety follow-up for vaccine development? Where AstraZeneca discovered that 20% of the subjects in their Corona vaccine trial were mis-dosed, just before FDA submission?
Can we rely on tech companies to use our clinical data for decisions that affect our lives ?
The third and biggest question, is can we rely on big tech with our clinical data?
Regulatory agencies, the global life science industry, and the big tech players all understand the immense value of our real-world clinical data. Amazon, Google, Apple, and Microsoft are intensely engaged in healthcare data processing and delivery. Without independent monitoring and verification, how can we rely on the FANG companies processing of our clinical data?
Join us on March 11 to help solve these amazing challenges!