Scientific & Regulatory Review

  • 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

    Read Post
  • 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

    Read Flipbook
  • New Blog: "Ask the IRB Experts"

    Visit Blog
  • 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

    Read Post
  • 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.

    Read Flipbook
  • 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

    Watch Video
  • 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.

    Read Flipbook
  • ×

    First Name
    Last Name
    Company
    Thank you!
    Error - something went wrong!
  • 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...

    Watch Video
  • 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.

    Read Flipbook
  • 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

    Watch Video
  • How Celgene Transformed Its Safety-Reporting Process, Saving $5.7 million In One Year

    How Celgene Transformed Its Safety-Reporting Process, Saving $5.7 million In One Year

    Read Flipbook
  • 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.

    Read Flipbook
  • Optimizing Global Safety Reporting in Clinical Trials54:41

    Optimizing Global Safety Reporting in Clinical Trials

    Learn how a large, global pharmaceutical company saved millions of dollars by optimizing their safety reporting process.

    Watch Video
  • Safety Reporting: It Can Enter the 21st Century, If We Let It

    Safety Reporting: It Can Enter the 21st Century, If We Let It

    Read Flipbook
  • Understanding the Challenges of Managing Combination Product Safety Reporting57:35

    Understanding the Challenges of Managing Combination Product Safety Reporting

    Watch Video
  • Finding an Agile PV Partner for Early-Stage Clinical Development

    Finding an Agile PV Partner for Early-Stage Clinical Development

    Read Flipbook
  • 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.

    Read Post
  • How Roche Optimized its Global Safety Reporting Process for Clinical Trials

    How Roche Optimized its Global Safety Reporting Process for Clinical Trials

    Roche recognized several major challenges that its CTSP 2.0 system needed to address.

    Read Flipbook
  • 4 Tips to Bolster Your Regulatory Strategy

    4 Tips to Bolster Your Regulatory Strategy

    Read Post
  • 5 Benefits of Outsourcing Expert Committee Management to an Independent Provider

    5 Benefits of Outsourcing Expert Committee Management to an Independent Provider

    Due to evolving practices and increased regulatory attention on Expert Committee operations, trial sponsors are benefiting by outsourcing committee management functions to an independent provider.

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

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

    Read Flipbook
  • loading
    Loading More...