Scientific & Regulatory Review
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56:30Watch VideoA Fresh Perspective from the FDA on the Final IND Safety Reporting Rule
A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule
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Don't Do It Alone: To De-Risk Your Next Trial, Seek Outside Expertise
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New Blog: "Ask the IRB Experts"
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Read FlipbookWCG Supports Small Oncology Biotech Through Rapid Growth, Saving Hundreds of Thousands of Dollars
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Read FlipbookHow WCG Statistics Collaborative Helped Breakthrough Therapy Obtain Regulatory Approval
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Relieving the Safety Reporting Burden on Sites: 4 Takeaways
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Read FlipbookSee How WCG Helped a Mid-tier Biopharma Respond to an Urgent FDA Request, and Adjudicate 400 Endpoints in Just a Few Short Weeks
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1:00:16Watch VideoThe Burden of Safety Reporting on Sites: An Oncology Site’s Perspective
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Case Study - WCG Trifecta Partners with Major Japanese Pharmaceutical Sponsor to Unify Management of Safety Records & 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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1:56Watch Video90 Second Insights: Safety Reporting in the Time of COVID-19
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Read PostNew Normal or Not, Safety Reporting Matters
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Read PostPeople, Process and Technology: The Right Combination for Successful Expert Committees
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Read FlipbookAn Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees
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Case Study - How A Top-Pharma Client Transformed Its Safety-Reporting Process, Saving $11.2 Million in One Year
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53:35Watch VideoStump 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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1:11Watch VideoAIMS 4.1 Promo
Custom-built to streamline the adjudication process, the AIMS platform allows for enhanced endpoint adjudication capabilities.
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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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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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Supporting NDA Submission for a Drug Targeting Menopausal Vasomotor Symptoms
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