Danny Lieberman, a trained physicist from Bar-Ilan University in Israel has been an active cyber security expert for years. In 2014 on a medical device consulting project he observed, much to his surprise, the intensive manual, paper-based environment surrounding clinical trials monitoring. He teamed up with Jenya Konikov-Rozenman, a clinical researcher trained at Hebrew University, to form Flaskdata.io to transform what they believed to be a major culprit in the way of faster drug development: Patient compliance automation for clinical trials.
Low Quality Data a Risk to the Patient-Centric Trial
The Flaskdata.io product helps clinical sponsors and CROs get a better handle of and better manage data quality as well as introduces automated patient compliance and improved protocol deviation management during patient-centric, decentralized clinical trials. Their system offers automation which they believe will help eliminate non-value-added labor and paper activities and hence can save up to 90% of study monitoring and clinical data costs. If these claims are valid—well, they are compelling.
A patient compliance automation platform, the solution was purpose-built for the emerging decentralized clinical trial—e.g. patient-centric interventions, site-less trials and even digital therapeutics requiring FDA-compliant study. They offer a list of 10 ways to reduce clinical trial risk.
Applicability of Flaskdata.io to Reducing Protocol Deviation
In traditional clinical trials, biopharmaceutical sponsors are squandering hundreds of millions per year on protocol deviations. The reality: increasing numbers of protocol deviations possibly convert to lower quality and higher costs. A number or ripple effects with direct and opportunity costs ensure. For example, patients can be excluded due to the flawed protocol design—necessitating the recruitment of more patients—which is already a very difficult undertaking in many therapeutic areas. The faster the patient recruitment, the better for the study.
Although the pair formed the venture in 2014 they spent two years intensely studying the patient compliance and protocol deviation problem, drug development and the overall market Flaskdata.io would enter. As they entered 2017 they secured their first batch of early adopters. The two founders, complemented each other in that one brought a technology and more business-oriented background and the other, science and clinical research.
Supporting Patient-Centric Trials
The nascent startup is making progress in what is a complex market with lengthy sales cycles. Currently the Flaskdata.io platform supports studies at over 350 investigational sites in Europe, the United States and Israel. The Flaskdata.io team works with life science sponsors and CROs to design, implement and operate patient-centric clinical trials. Their platform integrates continuous data feeds from a number of sources including patients, investigators and connected devices with automated detection and response to protocol violations in real time.
Patient Compliance Automation
The Flaskdata.io product was designed to help sponsors seeking to get their drugs approved faster to get a better handle on anticipating and managing patient compliance challenges. As clinical trials move toward more patient-centric, decentralized approaches; using even site-less trials with ubiquitous use of smartphones, sensors and other tools; data feeds from these sources become the key to better managed studies.
Hence, the product consumes continuous data feeds for automated detection and playbook response. The two founders can now show that their early adopter customers obtain an immediate picture of compliance posture. They position that 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.
A Platform for Decentralized Patient-Centric Studies
The Flaskdata.io platform, designed and developed in a “component architecture,” exposes functionality via their Flask API library. This commitment to interoperability and data sharing enables the next generation patient-centric trial: sponsors, digital health platforms, medical devices and digital therapeutics plug-in-and-play to the Flaskdata.io architecture.
Integrated in Multinational Biopharma Ecosystems
With an eye on scale and interoperability, the founder Danny Lieberman informed TrialSite News that the company is keen on applying the product capability and robust API suite to big biopharma ecosystems with integrations to clinical trial management systems, electronic data capture systems, and interactive response technology systems as an example.
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