Clinical Guest Contributors
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RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short
6/25/2026
Chiesi's Rachele Berria, MD, Ph.D., discusses how RWE is reshaping rare disease drug development strategies, from leveraging registries and patient-reported outcomes to navigating evolving regulatory expectations.
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AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them
6/25/2026
AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
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Will AI And Agile Project Management Help Advance RBM?
6/24/2026
Will AI-based tools embedded into risk based-monitoring prompt an Agile project management moment for clinical research? Sidharth Ananthanarayan explains why AI-based tools are not the answer but part of it.
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The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future
6/23/2026
The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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Why Building Long-Term Value And Making Clinical Progress Are Inextricable
6/23/2026
Dicot Pharma CEO Elin Trampe discusses how clinical milestones, financing strategy, shareholder value, and partnering considerations must be tightly integrated in early development through late-stage planning.
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What Sponsors Don't See: The Systems Behind Clinical Trial Delivery
6/22/2026
What do sponsors need from sites? Easy. How do they evaluate them? Not so easy (or accurate). In this column, Association Multisite Research Corporations (AMRC) Executive Director Jim Kremidas explains how sites and sponsors can make site evaluations better.
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What Really Happens At The Site When Sponsors Pull Back Mid-Trial
6/19/2026
When sponsors slow or reduce operational spending due to financial pressure, strategic pivots, or internal restructuring, sites — and patients — suffer. Curo Research CCO Amy Bland explains how sponsors can better manage operational changes.
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A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI
6/18/2026
Clinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.
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One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution
6/17/2026
Having the same number of clinical programs as team members might sound crazy, but for Step Pharma, it has become one of their biggest strengths.
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Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA
6/17/2026
For nonprofit organizations, Orphan Drug Designation is the start of a disciplined, forward-looking regulatory strategy, but it's not the only factor in success. H. Greg Thomas, Ph.D., shares his advice for de-risking orphan drug development.