CLINICAL EVENT VALIDATION AND ADJUDICATION

Clinical events committee management and endpoint adjudication solutions

With IQVIA Clinical Event Validation and Adjudication (CEVA) flagship committee management processes, you can be confident that the safety of your study's subjects will be protected, the scientific validity of the research upheld, and the ethical balance maintained. 

End-to-end Committee Management and Adjudication Support

IQVIA has spent years managing committees all over the world. Our unique resources, best practices and experience ensure expertise to design and deliver on an effective oversight group management strategy.
We have a proven track record for timely case closure and a reputation for high quality.

  • Expertise to design & deliver on effective committee management strategy with a broad knowledge base drawn from successful support more than 1,000 studies across multiple therapeutic areas.
  • Relationships with expert committee members allow rapid independent member identification and committee compilation and leverage long-standing working practices with committee experts.
  • Integrated, cross functional planning & execution ensure effective planning across stakeholders for delivery of project data reports.
  • Scalable, efficient clinical event data coordinating center with the ability to successfully resource and accomplish large volume workloads and flexibility to pare down to deliver lean solutions for smaller studies.
  • Quality: Quality is a priority within CEVA at all levels. We are proud of the tools and processes we have in place to establish and maintain quality both within the CEVA team and in the adjudication decisions derived by the committee. With an intricate understanding of regulatory expectations, CEVA maintains a high standard of quality and compliance through use of KPIs related to both timelines and quality, by not designing a process that is overly complex, and by providing training and supporting resources to sites.
  • Technology: Dedicated Internal Systems Team that CEVA partners and manages adjudication database vendors to design, build, test, and maintain electronic adjudication systems to record and track endpoints for adjudication.

CEVA CASE STUDY

Adjudication and Oversight Group Management

Adapting to COVID-19, IQVIA's CEVA team undertook a adjudication and oversight group management project which delivered a unique blend of innovation, technical expertise, and adaptative strategies, that was able to overcome tight timelines and meet client targets for their COVID-19 therapeutic trial.

CEVA WHITE PAPER

Establishing an endpoint adjudication committee and key endpoint management strategy

Some regulatory agencies are requiring or may soon require that both formally-designated clinical endpoints and other events of special interest (i.e., outcomes used in safety risk assessments) undergo centralized adjudication by an Endpoint Adjudication Committee, a panel of unbiased, independent experts responsible for reviewing and classifying potential efficacy and/or safety endpoints.

Learn why clinical endpoints are critical statistical measure points to help demonstrate drug safety and efficacy in clinical development and post-market settings.

Brainstorming meeting around table in modern office

CEVA FACT SHEET

IQVIA Clinical Event Validation and Adjudication (CEVA) – Protecting Trial Safety, Validity and Quality

Leveraging a highly experienced team providing an umbrella of solutions for global committee management oversight and effective adjudication strategies.
Go further with Clinical Event Validation and Adjudication
Our end-to-end Clinical Event Validation and Adjudication (CEVA) provides flagship level resources, best practices, and deep experience, ensuring center of excellence design and delivering an effective oversight group management strategy.
With its proven track record for timely case closure, integrated planning and execution, and reputation for high quality, IQVIA’s CEVA is able to offer scalable and efficient solutions that are unmatched in our industry.

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