Sentinel is a volunteer cross participation and verification system to avoid volunteer cross participation in multiple clinical studies/CROs. It ensures volunteer safety and the integrity of the study being conducted The system is now being actively used by multiple CROs in India. Volunteers are primarily identified by their biometric data(fingerprints/ facial/palm). Non–compliance related to completing study periods, missing ambulatory samples, increased screen failures due to cross participation are avoided.

Some of the salient features of the system are as follows:

  • Biometric based volunteer cross participation tracking system.
  • No personal information of the volunteer will be collected or stored.
  • Volunteer total exposure to the IP’s, total blood volume loss in a given year and overall volunteer health monitoring.
  • Improved commitment from the volunteers in completing a study successfully.
  • Efficient study planning and implementation.
  • Overall reduction in cost to conduct a study.
  • Confidence building measure with the sponsors.
  • Advanced search features. Customized and Adhoc reporting features.
  • Scalable software architecture.
  • Integration with other biometric databases.
  • 21 CFR Part11 compliant.
  • Validated system.
  • Solution was reviewed at client locations by US-FDA, UK MHRA, DCGI and regulatory authorities from various other countries, as part of study audits.
Data Management

Data management services