Scientific & Regulatory Review

  • WCG Trifecta Partners with Major Japanese Pharmaceutical Sponsor to Unify the Management of Safety Records and Increase Compliance

    WCG Trifecta Partners with Major Japanese Pharmaceutical Sponsor to Unify the Management of Safety Records and Increase Compliance

    WCG’s SafetyVigilance® Online Safety Event Solution Delivers Quality and Efficiency to Unify Enterprise Trial Management and Meet Regional Guidelines and Regulations

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  • 90 Second Insights: Safety Reporting in the Time of COVID-191:56

    90 Second Insights: Safety Reporting in the Time of COVID-19

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  • New Blog: "Ask the IRB Experts"

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  • New Normal or Not, Safety Reporting Matters

    New Normal or Not, Safety Reporting Matters

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  • People, Process and Technology: The Right Combination for Successful Expert Committees

    People, Process and Technology: The Right Combination for Successful Expert Committees

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  • How A Top-Pharma Client Transformed Its Safety-Reporting Process, Saving $11.2 Million in One Year

    How A Top-Pharma Client Transformed Its Safety-Reporting Process, Saving $11.2 Million in One Year

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  • Stump the Safety Experts Q&A53:35

    Stump the Safety Experts Q&A

    Our experts teamed-up to take on your safety questions and provide you with tactics and strategies to overcome the biggest challenges plaguing your studies today.

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  • AIMS 4.1 Promo1:11

    AIMS 4.1 Promo

    Custom-built to streamline the adjudication process, the AIMS platform allows for enhanced endpoint adjudication capabilities.

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  • Advances in Oncology Extend Lives, but Lead to New Safety Considerations for Sponsors and Investigators

    Advances in Oncology Extend Lives, but Lead to New Safety Considerations for Sponsors and Investigators

    From cardiovascular adverse events to complex dosing regimens, oncology trials present unique safety-related considerations.

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  • Safety Reporting Reference Model: Optimizing Global Safety Reporting in Clinical Trials using Local Laws46:42

    Safety Reporting Reference Model: Optimizing Global Safety Reporting in Clinical Trials using Local Laws

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  • Podcast: The Role of Expert Committees in Clinical Research with guest Jonathan Seltzer, MD, MBA, MA, FACC

    Podcast: The Role of Expert Committees in Clinical Research with guest Jonathan Seltzer, MD, MBA, MA, FACC

    Podcast
  • Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

    Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

    Something Has to Give: The Current Unsustainable Approach to Safety Reporting Puts Trials and Patients at Risk

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  • Case Study: Retrospective Endpoint Adjudication Committee

    Case Study: Retrospective Endpoint Adjudication Committee

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  • De-risking Clinical Trials Through Analytic Supported, On-Demand Medical Expertise From The World’s Leading Clinical Trial Experts

    De-risking Clinical Trials Through Analytic Supported, On-Demand Medical Expertise From The World’s Leading Clinical Trial Experts

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  • 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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  • Eliminating the Headache of Global Safety Reporting to Investigators and Ethics Committees32:32

    Eliminating the Headache of Global Safety Reporting to Investigators and Ethics Committees

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  • Optimizing SUSAR distribution in a connected– but unharmonized–world

    Optimizing SUSAR distribution in a connected– but unharmonized–world

    Steven Beales and Joe O’Rourke, vice president, business development talk through some of the difficulties Sponsors face when it comes to safety letter distribution, and how to overcome them.

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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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  • Don’t Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise

    Don’t Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise

    Due to evolving practices and increased regulatory attention on expert committee operations, sponsors are turning more to independent providers with experience in managing expert committees.

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  • A Small Company’s Experience Managing Safety and Risk Mitigation Without Infrastructure Spend34:46

    A Small Company’s Experience Managing Safety and Risk Mitigation Without Infrastructure Spend

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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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