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TOPIC 022 - TECHNOLOGICAL DEVELOPMENT AND VALIDATION OF REMOTE MEASURES FORUSE IN CLINICAL TRIALS IN INDIVIDUALS WITH RARE DISEASES

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N95022C00040
Agency Tracking Number: 75N95022C00040
Amount: $325,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 22
Solicitation Number: PHS-2022-1
Timeline
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
57 Chapel St, Suite 200
Newton, MA 02458-1080
United States
DUNS: 802270988
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Hung Nguyen
 (888) 589-6213
 hung.nguyen@biosensics.com
Business Contact
 Ashkan Vaziri
Phone: (888) 589-6213
Email: ashkan.vaziri@biosensics.com
Research Institution
N/A
Abstract

Conducting clinical trials for both rare and common diseases involve many challenges, some of the most frequent of which include the identification, enrollment, and retention of study participants. Virtual, decentralized, remote or site agnostic trials may be used to include individuals in studies that previously would have been excluded. Data that is collected will also need to be seamlessly captured and integrated from multiple sources and be of sufficient quality to meet regulatory requirements. Mobile technology offers the opportunity for remote participation and monitoring of study subjects, as well as remote and reliable data capture. Development and use of these technologies have the potential to allow for broader and more diverse study populations for participation in clinical trials for rare diseases while simultaneously improving the quality of data capture and efficiency of the trials. BioSensics will develop a robust and integrated multi-modal platform for data capture that can be used to assess individuals at their home and in remote settings for use in clinical trials. Specific Aims The objective of this project is to develop a robust and integrated multi-modal platform for data capture that can be used to assess individuals at their home and in remote settings for use in clinical trials. The technology will be reliable, secure, and easy to use to monitor study participants remotely, either in the home or while participating in activities of daily living. The proposed platform will allow measurements of motor, speech and cognitive functions using sensors and digitized clinical tests, as well as electronic.

* Information listed above is at the time of submission. *

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