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| RWE Is Not Optional, It's Essential | Guest Column | A conversation with Jennifer Timoshanko, head of medical strategy, bone health, UCB. | UCB Head of Medical Strategy, Bone Health, Jennifer Timoshanko explains why RWE is a valuable alternative to RCTs and shares best practices for collecting it. |
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| Unmasking Baseline Inflation In Clinical Trials | Article | By Marcela Roy, Sayaka Machizawa, Gary Sachs, and Alan Kott, Signant Health | Baseline inflation poses a major threat to CNS trial integrity by constraining the measurable range of improvement and obscuring true treatment effects. |
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| Unique IRT Implementation For Personalized Medicine Trials | White Paper | Almac Clinical Technologies | The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively. |
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| The Streetlight Effect | Article | Carebox | Examine the shortcomings of existing clinical trial finders, particularly regarding the accessibility of eligibility criteria for patients seeking treatment options. |
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| Gain Instant Access To HEOR Education With On-Demand Programs | Product | ISPOR—The Professional Society for Health Economics and Outcomes Research | The ISPOR Education Center provides instant access to HEOR education with on-demand programs delivered through a personalized, powerful, and flexible learning platform. |
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| At the Festival of Opportunity, we’re asking bold questions. Matthew Griffin, Futurist in Chief at the 311 Institute, opens with a look at how AI, IoT, and synthetic data are reshaping trials. Our largest-ever Regulatory Townhall welcomes regulators from six countries to explore global data governance. We close with Dr. Sara Brenner, Principal Deputy Commissioner at the US FDA, reflecting on COVID-19-era innovation and its lasting impact. Explore the #SCDM25 program. |
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| Where The FDA And EMA Stand On Digital Endpoints | Guest Column | By Anita Burrell, principal, Anita Burrell Consulting LLC | In part two of this series on digital endpoints, consultant Anita Burrell reviews the extent of their regulatory acceptance and discusses how to ensure data produced from digital technologies satisfies regulators. |
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| Revolutionize your approach to clinical trials at DPHARM: Disruptive Innovations to Modernize Clinical Research, taking place September 16–17, 2025, in Philadelphia. This conference showcases cutting-edge strategies and technologies designed to reduce patient and site burden, streamline operations, improve data quality, and accelerate access to therapies. |
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CHOOSE YOUR OWN ADVENTURE |
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| You're receiving the Wednesday edition of the Clinical Leader newsletter, focusing on Decentralized Trials and Trial Management. 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)
Learn more about our personalized newsletters here. |
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