BioSensics provides technical and global operation services to support and facilitate the use of wearable sensors and digital technologies in clinical studies and trials.
BioSensics provides global operations services to optimize the delivery of BioSensics’ solutions throughout all phases of clinical studies and trials. Our experienced team delivers exemplary service and novel technology to improve data quality and save time.
A dedicated and experienced clinical operations manager is assigned to each project to ensure end-to-end support of all BioSensics’ related activities throughout the life-cycle of the project.
Customization and validation of study-specific software
Timely site and sponsor/CRO communication
Device and ePRO compliance monitoring
Device provisioning logistics and timely delivery/tracking/ return of devices
User and Site Manuals
Data analysis and reports
Technical Support for Sites and Subjects
Study-specific data transfer specification
Data Quality and Subject Compliance Mentoring
BioSensics’ solutions are integrated with the BioDigit Cloud, a secure and compliant data collection and storage solution. Our experienced operations team assess the quality of collected data throughout the study to ensure compliance with regulatory and project requirements. BioSensics’ solutions enable centralized and objective collection and analysis of data for a wide range of endpoints.
BioSensics’ Compliance Monitoring service includes regular review of data in the BioDigit Cloud to quickly identify issues with wearing the sensor per protocol, ePRO response and diary compliance, device battery levels, and timely data transmission to the BioDigit Cloud. This service ensures subject compliance and any potential technical issues can be addressed quickly to improve data quality.
Technical and Scientific Consulting
BioSensics provides comprehensive technical and scientific consulting services to help meet your specific needs.
BioSensics’ research team has extensive experience in developing strategies for efficient patient data collection, and in creating and validating novel digital biomarkers for different diseases. This includes application of machine learning and AI, statistical modeling and analysis, and signal processing.
Identify appropriate digital biomarkers
Data collection strategies
Early Phase Study Collaboration
Early phase clinical studies play a key role in understanding disease symptoms, creating and validating novel digital biomarkers and developing tools and methods for objective assessment of endpoints. BioSensics partners with pharmaceutical, medical device and healthcare companies on early phase clinical studies.
Our highly qualified team of scientists, clinical operations staff and engineers provide expert services in protocol development, data analysis plan, software customization, and regulatory guidance to meet your unique needs. Additionally, BioSensics has established partnerships and umbrella contracts with several research institutions and hospitals across the United States, which can be leveraged to expedite study start-up.