Remote Biometric Device
Support

Deploying wearables and other remote biometric devices allows the capture of frequent or even continuous measures to characterize subjects’ experience or performance outside of confinement periods and study visits. Koneksa’s dashboards and reminders help to ensure appropriate use and compliance.


Electronic Clinical Outcome Assessments

Electronic Clinical Outcome Assessments (eCOAs) have been demonstrated to dramatically improve the reliability of patient reported data when compared to traditional questionnaires and diaries (Stone et. al. 2003 Controlled Clinical Trials). Koneksa’s mobile responsive software can drastically improve the accessibility of eCOAs, providing a cost effective and flexible platform to reach patients more frequently, on any internet-enabled device.
 


Real World Data Platform for Clinical Studies

Koneksa Compare is designed to ingest, monitor, audit and analyze high volume raw data streams that are not compatible with the leading EDC/ECRF systems or standard statistical software packages. The platform and supporting operations adhere to the international and U.S. regulatory guidance for the use of software, electronic data and protection of health information in human clinical studies.
 

Remote wearable device data monitoring software with an Actigraph device and mobile Cohero device

Device & Endpoint Selection

Koneksa's experience using clinically validated remote biometric monitoring devices with more than a thousand patients enables us to provide turnkey support to our pharmaceutical, biotech and academic customers for defining and validating subject generated and reported endpoints. We procure and deploy technology, then store, manage and analyze high volume raw data that are not supported by traditional EDC/ECRF systems and databases. Examples include:

  • Actigraphy (motion, physical activity and sleep)
  • Spirometry (complete remote pulmonary function tests)
  • ECG / vitals (single lead wearable patches for cardiovascular and respiratory measures)

Koneksa also provides custom integration, validation and qualification of devices and supports consumer grade technology where appropriate.
 

Clinical biometric data monitoring software

Data Monitoring

Koneksa Compare enables remote monitoring of the subject reported and generated high volume raw/continuous data to ensure the collection of the highest quality and compliant dataset. 

  • Real-time remote monitoring
  • Dashboard alerts for incomplete data
  • All transactions & system events audited
  • All data stored in a single common data format
  • Subject-facing interface (optional)
  • Role-based platform access for study staff

     
ePRO+monitoring+software+for+clinical+research+coordinators+and+ePRO+data+collection+software.png

Questionnaires & eCOAs 

Koneksa Compare provides intuitive questionnaire creation and scheduling functionality to ensure highest data compliance and real-time data collection.

  • Responsive & user-friendly interface
  • Automatically scheduled questionnaires
  • Manually released questionnaires
  • All transactions & system events audited
  • Industry standard instrument support
  • Works on tablets, smartphones, PCs and laptop computers

     
Mobile notifications for high ePRO data coverage

Reminders

Koneksa Compare enables sending scheduled automatic and manual reminders to study subjects from the Koneksa Compare dashboard. The reminders functionality is either enabled or disabled based on the study configurations.

  • Enabling / disabling reminders across study
  • Reminders for completing study items, filling questionnaires, and syncing devices
  • Email & text reminder support

     

CONFIGURABLE SOFTWARE

  • Fully configurable feature set
  • Linking with subject identifiers
  • Multiple subject identity types
  • Rolling subject enrollment date

SECURE TECHNOLOGY

  • AWS dedicated US hosting
  • SSL encryption
  • 24/7 vulnerability & antivirus monitoring
  • All transactions & system events audited
  • Subject identity protection

Browser COMPATIBILITY

  • IE 11+ Edge
  • Chrome 50+
  • Safari 9+
  • Firefox 46+ (Desktop only)

INDUSTRY GUIDANCE COMPLIANT

  • ICH – E6 Good Clinical Practice - (GCP)
  • FDA - Computerized Systems Used in Clinical Trials (CSUCT)
  • FDA – 21 CFR Part 11
  • HHS – Health Insurance Portability and Accountability Act (HIPAA)
 

 

Please contact us to learn more or request a demo of Koneksa Compare