Data driven clinical trials

 

 

Unified data platform

Flaskdata.io is a unified clinical data platform for early stage drug and device companies like you.   We believe that if you are developing cutting-edge therapeutics, you deserve cutting-edge data management technology at a price you can afford

    1. Collect data – Collect data from sites with DDC, from patients with desktop and native Android ePRO and from API calls made from connected devices and mobile apps.  You can bring your own code, devices, apps, wearables and systems. Plug in with Flask API
    2. Detect – You can define metrics of performance, missing outcome data and protocol violations.
    3. Act – When the metrics go over / under threshold, the system alerts clinical trial operations teams and reinforces patients with push notifications,.

Applications

Pre-submission clinical trials

Patient compliance is critical to the success of clinical research of neurodegenerative diseases, cannabis, migraine, rheumatoid arthritis, asthma, diabetes, atopic dermatitis, chronic constipation, pain management and heart failure.   Assuring and reinforcing patient adherence over time is particularly acute in home use devices and drug treatments.

Patient compliance assurance is often an FDA requirement for a regulatory study and not just a critical scientific requirement.

Flaskdata.io has patent-pending AI technology for monitoring and reinforcing patient compliance to the treatment protocol in regulatory clinical trials.

Our data monitoring engine enables us to develop specific compliance models from within our own labs to fit the needs of your clinical trial and enable you to achieve the highest levels of patient compliance and speed up your time to data analysis and regulatory submission.

Post-marketing research

The output of the patient compliance AI is an adherence strategy for your intervention based on your clinical evidence. This becomes the basis for a companion mobile app, private-branded for your intervention to help sustain high levels of patient adherence in real-life clinical practice.

Connected medical devices and digital therapeutics

Connected medical devices are typically wearables or home devices used by patients together with their mobile phone.

Automated deviation detection and response on the flaskdata.io platform for a connected medical device clinical trial is 100X faster than manual monitoring of the EDC. Automated compliance monitoring analytics and real-time alerts let you focus your site monitoring visits on work with the PI and site coordinators to take total ownership and have the right training and tools to meet their patient recruitment and patient compliance goals.

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