Subject Eligibility Validation


The C-VISA™ (Clinical Validation Inventory for Study Admission) is a customized composite inventory designed to ensure the right patients are enrolled in a trial. By incorporating information from multiple sources, we are able to verify the diagnosis, confirm symptom severity and establish subject validity for the study. Using Clintara’s proprietary software applications, and our easy to use audio/digital technology, the C-VISA™ is administered by the study rater, and reviewed independently by a Clintara clinician for confirmation. The C-VISA™ is a powerful weapon in the battle against placebo response, a leading cause of failed studies.

Site and patient-based misincentives can contribute to inappropriate subject selection which can derail a study. Surveillance of any kind will improve subject selection. Our approach is to undertake unbiased, rater-independent assessments to identify sources of variance (e.g. misdiagnosis, insufficient symptom severity, confounding factors) that may contribute to adverse study outcomes. We think it is important that this process be collaborative, and our site-independent review procedures therefore do not adversely affect enrollment timelines, or increase work at the site level.

The C-VISA™ was created with the knowledge that “dual” rater-independent reviews for subject selection can improve study outcomes.