Clinical trial technology is broken. Data collection happens on paper, storage in siloed servers and the study analytics is delayed by 4-6 months. The Pharma company operates in the dark when the trial is in progress. There are constant visits by trial monitors to keep the trial up to date. The trial physicians are exasperated by deluge of back and forth querying.
Finally the plethora of vendors who offer plug-in solutions that takes up time and effort to configure. All these inefficient processes add time and cost to drug trials.
iClinical is a real-time data aggregation, analytics and collaboration platform for clinical trials. We do this by collecting clinical trial data on protocol customized apps on a Android tablet. Store it in HIPAA compliant cloud servers and finally trial specific real-time analytics will be on study tablets. The data collection happens in front of the trial subject (eSource).
Now the study sponsor will know the status of the drug trail in real time – decisions on the direction of trial can now be made in real time. If the trial is not working, stop it immediately. If a part of the trial needs to be changed – do it ASAP!
Additional revenue - With cleaner data, drug gets to the market faster
Reduced costs - Drastically reduced data cleaning and monitoring costs
Stop non-working drug trials sooner - Increase your drug pipeline
We will get you up and running quickly. We will customize our product for your protocol, this includes all the data collection screens, analytics dashboards and visual analytics (graphs and charts). A traditional deployment for a phase 3 trial can take 6-9 months. We can complete this process in as little as 2-4 months. We add value by providing you with the right data aggregation/analytics setup for your clinical trial. You can leverage our scientific expertise in the trial start-up process and get it done right the first time.
Vertically integrated, end to end, out of the box solution :
Data aggregation, storage and analytics is one seamless function on our platform. There is no need for plug-in solutions from separate vendors/systems. Once the data collection begins for the trial, the preprogrammed trial metrics start filling in automatically. That means less time and resources wasted configuring different solutions.
Built-in security :
All the data from the Android tablet to secure cloud server is completely encrypted, the same happens once the analytics is fed back into the tablet. With an HIPAA compliant AWS server configuration, we can make sure that all your data is in one central, secure, safe location throughout the clinical trial and it is readily available for real-time reports and analytics.
Real-time analytics on the tablet with zero programming :
Pre-configured real time analytics means all the pre-programmed analytics dash boards and visual displays get populated as the data flows in. You will know up-to-the minute status of your clinical trial - the number of adverse events, serious adverse events, medications and all the trial end points displayed right on the tablet, in real-time. These metrics can be broken down by subject, site and country levels. Since the analytics is programmed at the start of the trial, there is no need for programmers to periodically extract data and run reports. Trial monitors can now remotely monitor the trial anytime/anywhere on the study tablet.
Actionable insights and trial metrics to stop non-working trials quickly :
The principal investigator can now monitor the trial remotely and get actionable insights in real-time, he can take crucial study decisions in real-time. If the trial is not working he can make the decision to stop the study immediately. If there is greater incidence of adverse events or trial end points, he can quickly change the course of the trial by making changes to the study. Stopping a non-working trial quickly can save tens of millions of dollars in lost time and personnel resources.
Remote monitoring :
With eSource and real time analytics, there is no need for frequent site visits by trial monitors; there is no traditional source data verification function on our platform. They can now monitor the trial remotely and issue/resolve trial queries remotely. This means there are massive cost savings both in number of monitors needed to monitor the trial and elimination of travel costs associated with frequent site visits. Monitoring costs can add up to 30-40% of trial costs, reducing or eliminating it can drastically reduce study costs.
Real-time issue resolution :
Real-time collaboration on a study tablet means time sensitive trial issues get resolved in real-time. Real-time secure chat on the platform means specific data issues can be discussed and closed out as and when they appear. Timely issue resolution means faster closure of study database, and faster study submission to the FDA.
Complete CFR Part 11 compliance :
There is a complete audit trail for all the data entered and changed during the clinical trial. There is a secure log-in for all the personnel involved in the study, there are also additional security measures, including GPS tracking and monitoring abnormal data entry/changes made in the system. Finally, the investigator signs off on all the data entered and changes made for the trial site. There is complete security and data encryption of all the trial activities from start of trial to database closure.
Pay per use solution :
Our software is provided as a service (SAAS), which means you only pay for the trials that use our product and only for the duration of the trial. If for any reason you stop a clinical trial early, you can close out the trial and pay only for the duration that the trial was conducted. There is no upfront license fee payment for software that you might not fully use. We charge a one time study customization fee at the start of the trial and an ongoing SAAS fee based on number of subjects enrolled in the trial. Once the trial stops you stop paying us.
iClinical is a pay as you go solution. Pay only for what you use. For more information contact us at firstname.lastname@example.org