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| Unlocking The Power Of Primary Care In Chronic Disease Research | Primary care physicians are a vital yet underused resource in chronic disease research. Engaging PCPs expands access to diverse patient populations, speeds patient identification, improves long term retention, and provides real world insights into treatment effectiveness. This session explores how to effectively involve PCPs, including their role in disease management, best practices for training and support, and navigating global regulations when integrating PCPs into clinical research. Click here to learn more. |
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| The Much-Feared FDA Form 483 | Guest Column | By Robert Califf | Dr. Robert Califf explains that FDA Form 483 is often misunderstood as a final judgment, when it is actually an initial notice of potential issues found during inspections. He argues the form should be seen as a tool for quality improvement, not a proxy for overall performance, and he calls for more efficient processes to reduce unnecessary anxiety and delays. |
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| SCOPE X is a premier event bringing together clinical research leaders to explore cutting-edge data strategies and AI innovation. Attendees will gain insights into advanced analytics, decentralized trials, and patient-centric technologies shaping the future of clinical development. With expert speakers, interactive sessions, and valuable networking opportunities, SCOPE X empowers organizations to accelerate trials, improve outcomes, and drive smarter, more efficient research. |
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| Avoid Clinical Alignment Breakdowns With "Lateral Agility" | Guest Column | By Fred Kohler, Kristen Chester, and Molly Rosen, ProjectNext | Internal misalignment can stall the clinical timeline, erode the window of patent protection, and jeopardize funding. Learn why leadership can no longer be and instead must exhibit "lateral agility" across the enterprise. |
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| Breaking Down Early Small Molecule Development | Article | Catalent | Adopt an integrated development strategy to streamline the path from early development to the clinic, ensuring timely clinical supply while reducing delays, risk, and inefficiencies. |
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| Translational Pharmaceutics For First-In-Human Studies | Brochure | Quotient Sciences | Re-engineer your drug's path into clinical development and accelerate time to Proof-of-Concept. Real-time data guides rapid formulation iterations, minimizing drug substance use and lowering program risk. |
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| When Clinical Trials Drift Off Course | Brochure | Biorasi | Recovering lost clinical trials is an art. Learn how we triage your study’s problem areas, build recovery strategies to address your drifting trial’s performance, and deliver results. |
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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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