Imaging
ICON Medical Imaging provides medical imaging based product development services that expedite drug development.
Electronic Adjudication Committee Management
Many clinical trials incorporate evaluation of endpoints for either efficacy or safety, by independent adjudication committees. Efficacy committees, Clinical Event Committees (CEC) or Adjudication Committees (AC), are comprised of physicians with expertise in the relevant therapeutic area.
The AC will review all relevant data, to provide an independent, blinded determination of trial endpoints or events. Historically most adjudication work has been performed in the academic sector, in a paper based environment.
A paper based environment relies on evaluation of paper CRFs, listings, videotapes, or films and does not allow simultaneous project tracking nor provide an optimal audit environment.
Despite high level physician expertise, the conduct of the committee can be affected by lack of real time access to all data in an electronic manner and the ability to easily identify multiple data.
Advantages of the Electronic Elements of the ICON Medical Imaging Adjudication Solution:
- Secure, remote access to all event data allowing independent adjudication and reducing/eliminating the need to bring AC members physically together
- Reliable and secure 21 CFR Part 11 compliant system with complete audit trails
- Secure (sFTP) transfer capability eliminates the need/cost of copying and shipping paper data
- Enhanced AC function through superior data organization and a logic driven adjudication eCRF
- AC committee data entry into an eCRF reduces errors and potential data loss
- Real-time access to adjudicated data for DSMBs through our reporting gateway
