Endpoint/
Clinical Event Adjudication Committees
Image
Adjudication Committees/
Core Laboratories
Data Safety Monitoring Boards/Committees
Steering Committees/
Advisory Boards
Early Phase Monitoring/
Dose Escalation Committees
IQVIA’s unique, flagship level resources, best practices, and deep experience ensure a center of excellence designs and delivers an effective oversight group management strategy. IQVIA – with its proven track record for timely case closure, integrated planning & execution, and its reputation for high quality – is able to offer scalable and efficient solutions that are unmatched in our industry.
IQVIA Clinical Event Validation and Adjudication
CEVA
Eligibility Review Committees
WHAT: An independent external expert committee that is composed of blinded therapeutic experts who focus on the adjudication of defined clinical events identified in the clinical study protocol.
WHEN: Phases I-IV
WHY: Adjudication provides a standard, systematic and unbiased assessment of endpoints to determine whether they meet protocol specified criteria.
Endpoint/Clinical Event Adjudication Committees
WHAT: An independent external expert committee that is composed of therapeutic experts and a biostatistician (if applicable) to review unblinded, accumulating patient safety (and potentially efficacy) data at pre-determined timepoints.
WHEN: Phases IIb-III
WHY: To protect vulnerable populations, address critical safety concerns and perform independent interim and final analyses to ultimately produce a recommended outcome.
Data Safety Monitoring Boards/Committees
WHAT: An independent external expert committee that is composed of blinded therapeutic experts who focus on the adjudication of diagnostic data points such as, high-resolution DICOM images (or pathology slides), ECGs, or spirometry as specified in the protocol.
WHEN: Phases I-IV
WHY: To assess and score the growth or decline of clinical manifestations at specific timepoints (via images or slides) per the protocol.
Image Adjudication Committees/Core Laboratories
WHAT: An internal expert committee that is composed of sponsor representatives, a PK/PD representative, a biostatistician, PIs (potentially), and representatives from the study operations team, who review subject profiles at pre-determined timepoints (cohorts).
WHEN: Phases I-II
WHY: To provide a recommendation regarding dose changes, toxicity issues and maximum tolerable dose.
Early Phase Monitoring/Dose Escalation Committees
WHAT: An independent external expert committee that is composed of blinded therapeutic experts who focus on the eligibility of potential subjects identified to participate in the clinical study protocol.
WHEN: Phases I-IV
WHY: To ensure a systematic screening of potential subjects and assess as well as validate the eligibility of subjects to participate in the clinical study.
Eligibility Review Committees
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WHAT: An expert committee that is composed of external (including PIs) and internal therapeutic experts to provide input/advice/direction on a vast spectrum of intricacies of a clinical study or program, including: protocol, deviations, CRFs, enrollment, efficacy and safety data, publications, abstracts, and emerging facets in the therapeutic area.
WHEN: Phases I-IV
WHY: To provide a record of guidance regarding the scientific conduct/future of the study, including the potential authorship of any study publications.
Steering Committees/
Advisory Boards
