Scientific & Regulatory Review
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New Normal or Not, Safety Reporting Matters
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People, Process and Technology: The Right Combination for Successful Expert Committees
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New Blog: "Ask the IRB Experts"
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How A Top-Pharma Client Transformed Its Safety-Reporting Process, Saving $11.2 Million in One Year
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53:35
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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1:11
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
From cardiovascular adverse events to complex dosing regimens, oncology trials present unique safety-related considerations.
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46:42
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
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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
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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
This publication discusses emerging cardio-oncology nuances and the latest regulatory thinking on ways to manage risks.
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32:32
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
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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13:58
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
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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34:46
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
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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54:41
Optimizing Global Safety Reporting in Clinical Trials
Learn how a large, global pharmaceutical company saved millions of dollars by optimizing their safety reporting process.
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Safety Reporting: It Can Enter the 21st Century, If We Let It
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