Bringing more than two decades of experience in event management in six major phase III NIH-sponsored and in several industry-sponsored clinical trials, ARCTEC has successfully coordinated management of thousands of outcome events. The NIH-sponsored trials have been published in prestigious medical journals and have defined the standard treatment in their respective disease areas, with the event definitions, adjudication, and reporting accepted without question by the scientific community and regulatory agencies.

ARCTEC offers the full range of trial event services:

• Development of specific definitions for trial outcome events that is consistent with prevailing standards and acceptable to regulatory agencies
• Drafting of the event-related portion of the trial manual of operations and trial-specific event committee charter
• Creation of data forms
• Training of research personnel collecting outcome data
• Collection and archiving of source documents
• Blinding of source documents regarding participant identity and treatment allocation
• Outcome event adjudication by expert clinicians
• Event tracking, through creation of a study-specific event database
• Event reporting both interim and final, to study sponsors and others
• Statistical analysis of events to determine event rates, independent predictors of events, and comparison between treatment arms