Services

We offer more than two decades of experience in event management of major NIH and industry-sponsored clinical trials

// Axio Research Clinical Trial Events Committee (ARCTEC) Services

ARCTEC has successfully coordinated the management of thousands of outcome events.

Our team offers more than two decades of experience in event management in six major phase III NIH-sponsored clinical trials, as well as in several industry-sponsored studies. 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:

  • Developing specific definitions for trial outcome events that are consistent with prevailing standards and acceptable to regulatory agencies
  • Drafting the event-related portion of the trial manual of operations and trial-specific event committee charter
  • Creating data forms
  • Training research personnel to collect outcome data
  • Collecting and archiving source documents
  • Blinding source documents regarding participant identity and treatment allocation
  • Assigning outcome event adjudication to expert clinicians
  • Performing event tracking, through creation of a study-specific event database
  • Producing and distributing event reporting, both interim and final, to study sponsors and others
  • Performing statistical analysis of events to determine event rates, independent predictors of events, and comparison between treatment arms
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