Scientific & Regulatory Review
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Read FlipbookAdvances 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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46:42Watch VideoSafety Reporting Reference Model: Optimizing Global Safety Reporting in Clinical Trials using Local Laws
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New Blog: "Ask the IRB Experts"
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PodcastPodcast: The Role of Expert Committees in Clinical Research with guest Jonathan Seltzer, MD, MBA, MA, FACC
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Read FlipbookSomething 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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Read FlipbookCase Study: Retrospective Endpoint Adjudication Committee
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Read PostDe-risking Clinical Trials Through Analytic Supported, On-Demand Medical Expertise From The World’s Leading Clinical Trial Experts
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Read FlipbookAssessing 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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32:32Watch VideoEliminating the Headache of Global Safety Reporting to Investigators and Ethics Committees
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Read FlipbookOptimizing 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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13:58Watch VideoThe 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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Read FlipbookDon’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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34:46Watch VideoA Small Company’s Experience Managing Safety and Risk Mitigation Without Infrastructure Spend
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Read FlipbookHow Celgene Transformed Its Safety-Reporting Process, Saving $5.7 million In One Year
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Read FlipbookQ&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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54:41Watch VideoOptimizing 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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57:35Watch VideoUnderstanding the Challenges of Managing Combination Product Safety Reporting
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Read FlipbookFinding an Agile PV Partner for Early-Stage Clinical Development
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Read PostUnique 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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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.
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