Subject Qualification

Rater Monitoring and Management CRS Clinical Rater Station CRS Clinical Research Expertise CRS Clinical Research Expertise CRS Clinical Research Expertise CRS Clinical Research Expertise Rater Training & Certficiation Subject Qualification Rater Monitoring & Management Data Analysis & Reporting

To achieve reliable results, Concordant Rater Systems (CRS) focus on consistency continues throughout the CRS Trial Management Lifecycle in Subject Qualification.

An accurate and thorough diagnosis is a critical and challenging component in managing study outcomes. CRS Subject Qualification solutions deliver increased clinical precision in both the diagnosis of the lifetime disorder (diagnostic validation) and current episode severity. Combined, the two offer a higher level of confidence that subject diagnoses are appropriate for the therapeutic area and meet study inclusion criteria for current episode severity.

The CRS diagnostic validation component of the Subject Qualification solution is a complement to DSM categorical diagnostic tools that provide actionable diagnostic information across the key clinical dimensions of a CNS diagnosis. Results are displayed on-screen immediately, so subjects with questionable diagnostic presentation can be excluded early in the screening process. Our practicing clinicians, experts in CNS research in clinical settings, review the diagnostic results in a collaborative manner with raters to provide:

  • Instantaneous, valuable information about the subject that can be utilized for additional probing required for diagnosis.
  • Quality assurance that subjects proposed for study inclusion meet diagnostic criteria.

CRS leverages the computerized assessments of the CRS Clinical Rater Station to confirm that subjects meet current episode severity thresholds, eliminating rater baseline inflation and a main source of placebo response in randomized studies.

The CRS Subject Qualification solutions are delivered on the CRS Clinical Rater Station and seamlessly incorporate all foreign languages.

Clients benefit from early identification of optimal subjects for enrollment to improve consistency and reliability of results.