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Flaskdata.io Reports on Theranica Therapeutics is Continuing on Post-Marketing Studies for Migraine Treatment Product

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Israeli tech company Flaskdata.io, which specializes in protocol compliance automation for clinical trials, has announced that their flagship customer Theranica Therapeutics is continuing their research on their Nerivio™ drug-free migraine treatment in two new post-marketing studies. It should be noted that Theranica’s Nerivio™ has been included in Time’s List of 100 Best Inventions of 2019. Nerivio™ is the first wearable device that is smartphone-controlled for the treatment of acute migraine. Similar customer case studies can be found on the Flaskdata.io website for those who are interested.

Alon Ironi, CEO of Theranica Therapeutics, says, “The ratio of compliance with the protocol is extremely high, and with the real-time alerts, we fix patient issues in a ‘short-loop’. This is a wonderful feature, and it makes the difference between a futile study and a successful one.”

Theranica is a biomedical technology firm that was founded in 2016 to engage in the development of advanced electroceuticals for migraine and other pain disorders. Nerivio™ was developed by the company for the treatment of acute migraine. It is placed on the upper arm and it makes use of electronic pulses that are regulated by a smartphone to provide remote stimulation of a Conditioned Pain Modulation response for reducing pain and tracking migraine episodes. The US FDA gave its De Novo approval for Nerivio™ in May 2019 and since then, the company had initiated the first phase of the product’s global launch. It is currently available in a number of select headache and migraine clinics throughout the USA.

Flaskdata.io offers a cloud platform for real-time collection of data during clinical trials and for automating protocol compliance monitoring. For those who are using a connected medical device for their clinical trials, they can collect data directly from their device by utilizing the open Flask Data API. Patients are able to report their outcomes using Flask Forms and all of the data can be monitored in real-time through the Flask Data remote monitoring platform. For wearable devices like the Nerivio™, compliance can be monitored by using the open Flask Data API and non-compliance can be detected by correlating changes or non-changes in vital signs.

Flaskdata.io explains that patient compliance is the single most crucial constraint that can affect the success of patient-centric studies, site-less trials, decentralized trials, home-use devices, and digital therapeutics. It the use of AI and playbook response that assures high patient compliance reporting and offers high quality risks signals from the first patient. Sponsors would be able to get an immediate picture of the status of patient compliance. The automation of the detection of protocol deviation can minimize costs and provide alerts on deviations at a speed that is more than 100 times faster compared to manual methods of central monitoring and risk-based monitoring services.

The Flask Forms is an app for interacting with patients and runs on desktops and mobile devices. It is possible to create an application in minutes by using a drag and drop UI. The Flask API of secure mobile/device API allows the client to gather data from mobile medical devices, and connected medical devices either at home or worn by the patient. Furthermore, the Flask API allows modification by the client because it exposes all of the Flask system functionality to developers from creating forms, adding subjects, user management, all the way to data extracts.

The Flaskdata.io Digital ingest system processes data at 100,000 events per second from all data sources or any data source in the client’s digital study, devices, investigators, and patients. And finally, the Flask Data Detect & Respond component processes the continuous data feed to quickly provide an overall picture of protocol compliance in a patient-centric research. Its automated monitoring module allows clients to specify their own clinical measures.

Those who are interested in the protocol compliance automation offered by Flaskdata.io may want to check out their website. As a way to contact for more information, the company can be reached by telephone or through email.

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About Flaskdata.io :

We help life-science CxO teams outperform their competitors.

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Flaskdata.io

48 Emek Ayalon
Modiin, Israel

+972-54-447114

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