Industry Insights
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Rethinking RTSM Software: When Bigger Isn't Better
3/9/2026
Don’t let legacy vendor inertia jeopardize your trial. Discover why agility and deep RTSM expertise are the new benchmarks for reducing risk and ensuring precision in clinical operations.
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Mid-Study RTSM Migration: How To Switch Vendors Without Disrupting Your Trial
3/9/2026
Evaluate the risks of staying with an underperforming RTSM provider versus the benefits of a mid-study transition. Modern migration tools now offer a secure path to protect trial data and timelines.
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The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development
3/9/2026
Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.
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Direct-To-Patient Strategies Helping CRO Exceed Enrollment Targets
3/6/2026
This deep dive into a successful rescue mission of a Type 1 Diabetes clinical trial reveals how shifting to a direct-to-patient digital strategy can turn a failing timeline into a success story.
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Avoid Clinical Alignment Breakdowns With "Lateral Agility"
3/6/2026
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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Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
3/6/2026
The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.
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Clinical Research Update: The New FDA Form 1572 is Available
3/5/2026
Stay current with the latest FDA investigator filing updates. Learn when to transition to the new version and how to maintain compliance without unnecessary administrative re-work.
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FDA Updates Guidance For Written IRB Policies
3/5/2026
Explore how updated FDA and HHS guidance harmonizes regulations, streamlines IRB operations, and strengthens oversight for complex clinical trials.
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Challenges That Derail Bladder Cancer Trials And How To Anticipate Them Earlier
3/5/2026
From the rapid evolution of standard-of-care benchmarks to the logistical strain of procedure-heavy urology workflows, the path to a successful endpoint is filled with operational friction.
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The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board
3/5/2026
Tufts CSDD’s Beth Harper shares findings from the org's latest Impact Report and discusses how companies might better define risk, measure success, and understand central monitoring.