Key Benefits:
Clinical Events Committee
- Manage user access and support internally
- Configurable workflow driven endpoint event adjudication process
- Blinded and Committee based models available out of the box
- Increased efficiency due to remote adjudication capabilities
Adjudicators
- Review and adjudicate assigned endpoint events remotely
- Increased productivity due to availability of electronic source documentation and support for e-signatures
Key Features:
Adjudication Matrix
- Drill down reports and filters for quickly scanning through hundreds of events and adjudication states
Multiple Adjudication Models
- Blinded: Two or more adjudicators working independently providing an unbiased assessment of endpoint events relationship to study drug
- Committee: Collaborative approach to adjudication, allowing multiple reviewers with a single chairperson as the primary signatory
Source Documentation Access
- Provides Clinical Event Committee Managers with quick access to all source documentation for easy redaction and file organization
- Adjudicators receive online access to redacted source documentation
Electronic Signatures
- 21 Part 11 compliant e-signature functionality
Event Querying
- Blinded stream of communication between sites and adjudicators
- CEC Staff is given full control of the communication stream