Today's clinical trials are relying upon clinical endpoint adjudication, the assessment of patient events or outcomes, with increasing frequency. Clinical Endpoint Committees (CEC) are formed for a study, consisting primarily of physicians, to review all relevant documents and provide adjudication. However, the timely completion of assessments are regularly challenged by the logistics of performing these reviews in a paper environment. A lengthy adjudication process limits the ability for sponsors to make timely decisions based upon review committee findings.
Perceptive's Virtual Clinical Adjudication System (VCAS) is a web-based application that facilitates central management of adjudication activities.
When an event or endpoint occurs for a subject, relevant clinical documents are collected in VCAS to create an electronic dossier. Once a dossier is complete, VCAS enables reviewers to analyze the appropriate dossier and record their assessments, with built-in edit checks to ensure collection of clean data at the time of entry. The completed reviewers' assessments are compared by the system, and if discordance is found, the dossier is automatically reassigned for tiebreaker review. Workflow and electronic query tools available within VCAS steamline the review process enabling the process to be highly efficient.
Our VCAS is designed with flexibility in mind. The application can operate in either a hosted or licensed environment, and can accommodate any number of users and reviewers with specific privileges based on their role. It is possible, based on the needs of the trial, for the various tasks of collecting clinical data and creating patient dossiers to be performed centrally, or by users located at different organizations, such as trial sponsor, CRO or independent review facility.