Medical Research: Rebuilt, Retooled and Rebooted An early stage mobile medical device company developing a human-centered suite of consumer products using science and technology to empower everyday people to monitor and better understand their own health—anytime, anywhere.
2. Summary
Medical Research: Rebuilt, Retooled and Rebooted An early stage mobile
medical device company developing a human-centered suite of consumer
products using science and technology to empower everyday people to monitor
and better understand their own health—anytime, anywhere.
The traditionally conducted clinical trial models need increasing amount of time,
cost, and resources for both sponsors and sites. Only fewer than 10% of clinical
trials are completed on time due to poor patient recruitment and budget
negotiations. Since 2008 per-patient, clinical trial costs in the US has raised by
an average of 70% across all growth phases.
3. Rebuilt
At Scanadu, data collection and clinical studies are key to the development and
deployment of medical devices. And as a startup developing the next generation of
medical devices for consumers, they had to innovate the clinical study process,
while defying the traditional assumptions related to a clinical study.
In May 2013, they initiated the most successful crowd-funding campaign for a
medical device on Indiegogo , because they wanted to standardize this campaign
and its platform to put together their FDA study. Over 8,000 people backed the
campaign.
They associated with Scripps Translational Science Institute (STSI) and, after
cautious preparation, officially launched the SCOUT study for the investigatory
medical device in early 2015.
4. Retooled
All platforms were HIPAA-compliant, all content was Institutional Review
Board (IRB) approved and an electronic informed consent form was used.
More than 75% of all backers based in the US signed up for the study, and
in the latest survey more than 90% of them expressed that they would be
willing to participate in such a study again.
Anyone who enrolled in their study – or is currently using Research Kit in a
study such as GlucoSuccess, Asthma Health, Parkinson mPower, or
MyHeart Counts – will definitely agree that using an eICF presents many
opportunities and advantages for both sponsors and participants.
Using a HIPAA-compliant platform for the ICF process has eliminated
major problems includi
5. Rebooted
The SCOUT study has an unequaled enrollment rate for a medical device,
and while there were challenges, this success is due to the transparency of
the process, the incredible engagement from the participants, and the full
use of today’s technology .
Access to information, knowledge and rapid development of technologies
has an unequaled impact on the progress of science. If many people
participate in clinical research trials like this then mode development can be
made in the field of Clinical Researches.
Among many institutes and organizations our CRB Tech Solutions has
created a niche in providing Clinical Research Training.
