The story

The idea for patient compliance automation in clinical trials and real-life was born over a bottle of wine. I had been involved with Fidelis Security and after the company was sold to General Dynamics, I was between gigs. A friend of  a friend introduced me to an Israeli CRO who needed some technical assistance in a clinical trial of a medical device in the psychiatric space. I didn't do much but after the customer received their 510(K), the CRO invited me to a cooking class to celebrate the successful submission. The entire clinical space was new and strange to me especially the part of SDV, site visits and all the people and paper-intensive processes.
I was paired off to cook with the study bio-statistician and she lamented how primitive the data collection and monitoring was from her perspective.  Coming from Fidelis Security data loss prevention technology that provides automated real-time detection and response; the notion of taking 6 months to clean data seemed about 50 years behind the times.
By the time we finished cooking (and a bottle of wine) -  we had the vision:  automated real-time detection and response of safety and compliance violations in clinical trials. The value of real-time detection and response in clinical trials Time waiting for SDV and site visits is time burning money and delaying revenue. Consider a pipeline with revenue EU 500M/year that is delayed by 6 months due to non-compliant patients and undetected defects. Every month saved by improving compliance and detection, pulls in EU 41.6M of revenue.

FlaskData - Big data tools for small data clinical trials

FlaskData is an Israeli tech startup that addresses one of the biggest global challenges in healthcare today - fast, compliant and cost-effective human clinical trials for delivery to market of innovative drugs and devices and does so by addressing a common concern for both patients and researchers: How to enhance patients’ ability to adhere to treatment protocol?
The technology was designed to meet the highest regulatory (21 CFR Part 11) information technology and data security and privacy requirements (HIPAA, GDPR) for online clinical data collection and clinical data monitoring that enables life science companies to detect deviations 30X faster than on-site visits.
FlaskData is a family of SaaS products for global on-demand management of clinical trials: Flask EDC, Flask ePRO, Flask API for medical IoT and Flask Analytics for automated detection and response of protocol deviations that enable you to collect data and enforce compliance using on-demand cloud services.
FlaskData is based on novel, patent-pending cloud technology for managing and improving patient compliance to treatment that connects the dots between clinical research and medical practice.
FlaskData is the ideal platform for innovative chronic disease and medical device sponsors who need to move fast and ensure the highest possible level of patient compliance.

SIMPLE AND SECURE

Robust – high availability, high performance cloud services at Amazon AWS
Consume FlaskData like a utility, pay as you go.
Secure, private, GDPR and HIPAA compliant
Guaranteed data portability – your data whenever you want it. However you want it.
Reliable–24x7x365 system monitoring, backup and disaster recovery
Perfect for chronic-disease and medical device clinical trials. Technology packaged in unlimited usage monthly subscriptions enables you to focus on delivery instead of technology and contracts.
21 CFR Part 11 compliant and validated to latest FDA regulations
HIPAA and GDPR compliant