Clinensure is a browser based end to end BA/BE management solution. The volunteer management is primarily based on fingerprint based biometrics. Biometric based optional secondary identification mechanism is also available within the system. Independent pre-screening module is available to create a pool of eligible volunteers to be considered for any given study. Strong integration between pre-screening activities and study specific activities to ensure data integrity for the final study data completion and submission.

Salient features of the solution are :

  • NIST certified biometric solution.
  • Biometric based volunteer enrollment and identification mechanism.
  • Pre-screening module.
  • Study creation and study enrollment features.
  • Volunteer and Study subject ID card generation.
  • Study specific E-CRF generation.
  • Instrument integration for laboratory results.
  • QA module, to review all the study CRFs with a click of a button, to identify protocol deviations.
  • Discrepancy note management.
  • Configurable data import features.
  • Custom study closure features to end the study in batches.
  • CDISC compliant data export features.
  • Direct integration with SAS tools.
  • HIPAA, GCP and 21CFR Part 11 compliant.
Data Management

Data management services