Data collection on study apps + Secure Cloud Storage + Real-time analytics on study tablets
We configure everything for you. Send us the protocol and we will give you a study app that is first patient-first visit ready
We manage the study for you. We take care of the back end infrastructure for the duration of the study
Pay only for what you use. Our SAAS model is based on number of subjects/data for the study. There are no expensive upfront license costs.
Quick trial start-up:
Includes trial app with any patient reported outcomes, IoT and medical device data. Data entry is in front of the subject, its eSource as per FDA.
Machine learning models to automate data cleaning:
Machine learning models are used to clean the trial data. The models will identify discrepant/inconsistent data at the time of data entry. And once all the data is in the database, it again rescans the data for consistency and issues auto-queries the site. Additional models will be used to clean up AE/Medication coding.
Risk based monitoring based on ML models:
Real-time monitoring of trial sites would involve precise identification of sites and data that needs to be monitored. This prevents waste of blanket onsite monitoring visits.
Predictive analytics for trial projections:
Real-time projects allow the pharma's to monitor the trial closely; it allows them to close out non-working trials faster and for trials that are working - they can speed them up and get the drug to market faster.
Fully secure and FDA 21 CFR Part 11 compliant:
There is full encryption of the all the trial data between study tablet and AWS servers. AWS database instances are segregated, HIPAA compliant and fully secure. And the platform fully adheres to 21 CFR Part 11 guidelines (full Audit trail, investigator signatures and secure authorized permissions).
Our future proof technology platform is ready for remote and adaptive trials. ML models can unearth new paths in real-time, making adaptive trials feasible. With a mobile/cloud data platform, iClinical is perfect for remote clinical trials.
iClinical is a software as a service solution. Pay only for what you use. For more information contact us at firstname.lastname@example.org