Flaskdata.io provides an integrated data collection and automated monitoring platform for clinical trials.
Patient compliance is the single most critical constraint for the success of patient-centric studies, decentralised trials, site-less trials, digital therapeutics and home-use devices.
Continuous data feeds drive automated detection and playbook response. Sponsors can obtain an immediate picture of compliance posture. Automation of protocol deviation detection reduces cost and delivers alerts on deviations over 100X faster than current manual methods of central monitoring and risk-based-monitoring services.
The platform is built in a component architecture which exposes functionality via the Flask API. This enables sponsors, digital health platforms, medical devices and digital therapeutics to easily pick and choose what functionality they want to implement on the Flaskdata.io platform.
Flask Cloud EDC is a full-function 21 CFR Part 11, HIPAA and GDPR Compliant Web application for collecting data in regulatory submission and post-marketing studies.
The Web application includes eCRF forms, edit checks, query management and data extract to CSV and CDISC ODM formats.
A rich set of API functions is exposed to enable your developers to embed Flask EDC as the regulatory data collection component in your system.
Flask API is a powerful secure mobile/device API service that enables you to collect data from mobile medical devices, and connected medical devices at home or worn by the subject.
However, Flask API does not stop there. Flask API exposes all of the Flask system functionality to developers from adding subjects, creating forms and user management all the way to data extracts.
Perhaps the biggest challenge in decentralised trials, site-less trials and digital therapeutics is having a robust capability to digitally ingest data from a wide variety of sources.
The flaskdata.io Digital ingest system ingests data at 100K events/second from any or all data sources in your digital study; investigators, devices and patients.
Detect & Respond processes the continuous data feed to provide an immediate picture of protocol compliance in your patient-centric research.
The automated monitoring module enables you to define your own clinical measures.
The real-time monitoring robot generates real-time alerts and analytics for your site and clinical operations teams.
Automated playbooks provide adaptive reinforcement messages for patients in their own time and treatment frame and help them achieve high levels of adherence.