Electronic Event Adjudication


Experience and technology combine to deliver the leading adjudication services in the clinical research marketplace.

Experience and Technology

ICON combines the extensive experience of our skilled panel of physician adjudicators, specialised project management and clinical outcomes nursing staff with state of the art technology to deliver the most sophisticated and efficient adjudication services in the clinical research marketplace. ICON’s olution is fully customisable to suit all adjudication requirements, no matter how complex. Our library of adjudicator eCRF logic and paradigms in the areas of MACE (Major Adverse Cardiac Events), in addition to other safety and efficacy parameters, can be readily assembled into a fully compliant framework which fits all adjudicators’, sponsor’s and regulatory authorities’ data delivery needs.

ICON’s Electronic Adjudication System

The Electronic Adjudication Platform is a key component of MIRA™, one of ICON’s 21 CFR Part 11 compliant tools for clinical research trial management. This system underpins the Electronic Adjudication Committee workflow, manages the source information and data required for the event adjudication, allowing expert adjudicators to work remotely and independently. Having immediate access to a central repository of real-time data eliminates the costly, labour intensive and complex paper-based workflow where review and adjudication was accomplished by periodic, in-person, group meetings that reviewed several hundred paper-based events per session. The use of an electronic system with adjudicator-specific eCRFs eliminates the need for third-party transcription and data entry, which increases efficiency and decreases the potential for data entry errors.
 

Benefits of secure, remote access

The benefits of using ICON’s secure, remote access to our adjudication system include

  • Secure, remote access to all event data, allowing independent adjudication and reducing/eliminating the need to bring Adjudication Committee members physically together
  • Controlled environment to ensure patient confidentiality and document security
  • Reliable and secure 21 CFR Part 11 compliant system with complete audit trails
  • Secure (sFTP, HTTPS) transfer capability eliminates need/costs of copying and shipping paper data
  • Adjudication Committee function is enhanced through superior data organisation and a logic driven adjudication eCRF
  • Adjudication Committee data entry into an eCRF reduces entry errors, and reduces potential for data loss
  • Real-time access to adjudicated data for DSMBs through our reporting gateway