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| 3 Views From Inside FDA's RTCT Pilot | From The Editor | By Dan Schell, chief editor, Clinical Leader | The FDA's RTCT pilot promises to bring clinical trials into the real-time era, but questions remain about governance, oversight, and implementation. We asked three organizations participating in the initiative what they see as the opportunities, challenges, and realities behind the FDA's most ambitious modernization effort in years. |
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| Capture Was Step One. Execution Is Step Two | Article | By Abraham Gutman, AG Mednet | Electronic data capture transformed clinical trials, but advancing a study depends on decision workflows that interpret data, coordinate teams, and determine meaningful next actions. |
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| Rethinking Patient Representation In Breast Cancer Trials | Article | By Claudia Marques Vasconcelos, M.D., Parexel International | Broad patient representation in breast cancer trials is critical, and inclusive trial design improves data relevance, accelerates enrollment, and supports global approval and access. |
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| Real-Time Data... Are We Fixing The Right Bottleneck? | Article | By Derk Arts, M.D., Ph.D., Castor | Real-time data streaming to regulators is a bold step, but true clinical acceleration requires solving site-level bottlenecks and data silos to reduce the administrative burden on research. |
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| End-To-End Safety Solutions Designed For Success | Datasheet | IQVIA Safety & Regulatory Compliance | As one of the world’s largest and most experienced safety and PV organizations, unearth how this provider is bringing extensive expertise and regulatory intelligence to every industry engagement. |
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| Judgement-Based Project Management Builds Partners' Trust | Guest Column | By Jason C. Bork, Pintail Solutions | Project managers often operate under rules that govern how and when they execute tasks. But that doesn't always include room for individual judgment. But judgement, argues Jason Bork, is the differentiator in successful partnerships. |
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| Why Use Scorecards To Make Vendor Selection Decisions | Article | By Kalyan Obalampalli, ClinAI | Scorecards enable structured, unbiased vendor selection by transforming complex clinical trial decisions into transparent, data-driven evaluations — ensuring operational excellence and regulatory compliance. |
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| Open-Label Study Assessing Relative And Absolute Bioavailability | White Paper | By Andy Sykes, Helena Engman, Nigel Taylor, Tim Brier, et al., Quotient Sciences | Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions. |
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| Diversity In STEM Scholarships In APAC, North America | Brochure/Flyer | Avance Clinical | With a strong focus on the Life Sciences industry, this program provides financial assistance, hands-on industry experience, and international visibility, creating a more diverse and inclusive future. |
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| Creating Powerful Partnerships | Brochure | ISPOR—The Professional Society for Health Economics and Outcomes Research | Deepen your impact in global healthcare through thought leadership, education, conferences, and partnerships that elevate visibility, strengthen expertise, and connect you with key HEOR stakeholders. |
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| You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences. - Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
- Clinical Trial Technology (Tuesday)
- Decentralized Trials | Trial Management (Wednesday)
- Outsourcing Models | Regulatory & Compliance (Thursday)
- Clinical Data Management & Analytics | Trial Monitoring (Friday)
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