Clinical Guest Contributors
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Why The ‘Illusion’ Of Speed In Clinical Trials Unravels As Contracting Demands Scale
3/19/2024
Discover four mistakes biotechs often make in haste (and how to avoid them) as they hurry through clinical trial contracting on the path to commercilization.
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Informed Consent In Clinical Trials: Understanding The FDA’s And OHRP’s Joint Draft Guidance
3/18/2024
The FDA and OHRP have jointly issued a new draft guidance about how sponsors, investigators, and IRBs should structure and present informed consent documents to clinical research participants.
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What’s Needed To Keep Tinnitus Research From Going Quiet
3/18/2024
Finding effective treatments for tinnitus has often been circuitous and frustrating for many patients. Tinnitus expert Marc Fagelson, Ph.D., explores the current treatment landscape and what can be done to improve outcomes for patients.
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Could Consolidating Independent Sites Into Site Networks Be The Research Revolution We Need?
3/15/2024
The formation of clinical trial site networks appears to be rising in popularity. Understand how these integrated networks can contribute to more effective, patient-centric trials — if done correctly.
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A Better Recipe For Sourcing Your Clinical Trial
3/14/2024
Is outsourcing still the optimal pathway for conducting clinical trials in the 21st century? A better recipe for success might include insourcing and functional service providers (FSP), sprinkled with a handful of outsourced tasks, for a more stress-free and agile clinical trial experience.
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A Structured Approach To Regulatory Information Management Vendor Selection
3/13/2024
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
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Supplying Complex, Controversial, And Intercontinental Clinical Trials
3/13/2024
Planning a clinical supply strategy for a complicated substance, psilocybin, is tricky. It's even more tricky doing it from the other side of the planet. Here's one company's approach.
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4 Takeaways From Building A Differentiated Franchise In Clinical Immunology
3/12/2024
Immunovant CEO Pete Salzmann, MD, MBA, shares what he and his young company have learned about developing the right workforce, selecting viable targets, listening to patient needs, and trying alternative trial designs.
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Navigating China's Biologics Approval And Accelerated Pathways
3/8/2024
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Community-Driven Registries Drive Understanding Of Rare Diseases
3/8/2024
In an effort to increase and diversify research, the Pulmonary Fibrosis Foundation (PFF) envisioned a new approach to aggregating usable medical data — asking patients directly.