Clinical trials — a case for reform

Data management in clinical trials is currently a broken process. Data collection happens on paper, it is then entered in hospital/clinic computers and finally the data ends up in pharma company servers. Data getting into servers can take anywhere from 15–30 days from the date of subject visit. This data will have transcription errors and there could be missing data, all of which leads to further delays.

And analysis of data that is in the Pharma company servers happens much later — 4–6 months later, during which the pharma company operates in the dark

iClinical will change all that.

iClinical is real time data analytics and collaboration platform for clinical trials. We help pharma companies bring life saving drugs to the market sooner and at a lower cost.

We do this by collecting data at the source — during the subject visit in front of the subject. Industry term for what we do is eSource — collect data once and at the source, and do it electronically. Once collected it gets stored in HIPAA compliant cloud servers and real time analytics happens immediately after that. The analytics is on study tablets and is completely pre-programmed for the clinical protocol.

So what does iClinical process do for the Pharma company:

• Drug gets to market sooner: Since data gets entered at the source and gets cleaned faster (queries are issued/resolved in real time) — trial closure happens faster and the drug gets to the market sooner. So what does it mean for a pharma company, they can expect an additional revenue of $100 -$400 million, that is 4–6 months of revenue of newly approved drug.
• 30%-40% savings on trial costs: This is due to lower levels spent on two key functions in clinical trial; data cleaning and monitoring. Reduced data cleaning because data gets entered at the source and the source data verification function as we know it, will disappear. Trial data and analytics on a android tablet means the trial can now be monitored anywhere/anytime remotely, reduced or complete elimination of site visits means reduced trial costs.
• We can stop trials that are not working quickly. Right now, the decision to stop a trial is made 6–8 months after the trial has actually stopped working. With real-time analytics we can stop the immediately and re-deploy the resources to other working trials.
• With our software as a service solution, we can save pharma companies the cost of up front investments in computer hardware and software. The trial can be quickly started in short notice and it can be closed out as soon as the trial is done. The pharma company only pays for the trials it uses our platform and only for the duration of trial (>90% of pharma company trials fail).

So what does iClinical do for the patients and the society:

• Since the drug gets to the market sooner the patients get to use the drug immediately and get relief. If it is for a life saving drug, like a cancer therapy, a few months delay in drug approval means an additional life gets saved or not.
• In the long run, it also means lower costs for prescription medicines, since pharma companies spend billions of dollars on research, recouping those costs requires them to price medications at high prices. With a cost saving drug development platform, the cost of developing new drugs should come down and these savings would be passed on to end consumers.