Jonathan Seltzer

Content created by Dr. Jonathan Seltzer, Chief Scientific Officer, WCG ACI Clinical

  • Assessing Cardiac Safety in Oncology Drug Development

    Assessing Cardiac Safety in Oncology Drug Development

    This publication discusses emerging cardio-oncology nuances and the latest regulatory thinking on ways to manage risks.

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  • Q&A: The Role of Expert Committees and the Regulatory Landscape

    Q&A: The Role of Expert Committees and the Regulatory Landscape

    Dr. Seltzer, president and founder of ACI Clinical, and chief scientific officer of WCG Clinical, shared his insights on expert committees during a recent conversation with Bill Stedman.

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  • The Role of Expert Committees: An Interview with Dr. Seltzer13:58

    The Role of Expert Committees: An Interview with Dr. Seltzer

    What’s the role of expert committees today? What’s happening on the regulatory side? Dr. Seltzer, Chief Scientific Officer of WCG Clinical, shared his insights on expert committees during a recent...

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  • Unique Challenges for Medical Device Clinical Trials

    Unique Challenges for Medical Device Clinical Trials

    Adjudication of events of interest can support overall study integrity and ensure reliable, consistent definitions are provided to regulators and the scientific community.

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  • Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing ev

    Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing ev

    This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “The Role of Endpoint Adjudication in Medical Device Clinical Trials”.

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  • Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective

    Clinical event adjudication in cardiovascular device trials: An Food and Drug Administration perspective

    In this issue of the journal, Jonathan Seltzer presents an important review of the rationale and best practices for event adjudication in medical device clinical trials.

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  • DMC Regulations May Change, but Principles Won't

    DMC Regulations May Change, but Principles Won't

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  • Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharrmacologic trials

    Centralized adjudication of cardiovascular end points in cardiovascular and noncardiovascular pharrmacologic trials

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  • Clinical event adjudication in cardiovascular device trials-FDA Perspective

    Clinical event adjudication in cardiovascular device trials-FDA Perspective

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  • Use of Endpoint Adjudication to improve the quality and validity of endpoint assessment for Medical Device Development

    Use of Endpoint Adjudication to improve the quality and validity of endpoint assessment for Medical Device Development

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  • Responsibilities of Data Monitoring Committees: Consensus Recommendations

    Responsibilities of Data Monitoring Committees: Consensus Recommendations

    This article provides a practical guide to sponsors, institutions, and individuals responsible for, or serving on, a DMC.

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  • An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees

    An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees

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