Radioligand therapy (RLT) trials demand specialization. Affibody's Fredrik Frejd explains how they differ in design and execution from standard oncology Phase 1 studies.
- Firsthand Findings: How Incannex Is Designing Trials That Support Regulatory Approval
- The 2026 Pharma R&D AI Sourcing Map: Partnerships, Concentration, Inflection
- Lupus Researchers Now Have A Three-Pillar RWD Platform To Support Discovery And Development
- Novel Science, Familiar Regulatory Pathways: Inside Tonix's Clinical Development Strategy
- As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient Access
- Walmart's Clinical Trial Model Faces Its Real Test
- A Window Into Aging: Why Skin Is the First Test For RLS-1496
GUEST COLUMNISTS
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![US map healthcare icons-GettyImages-522620544]( "As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient Access")
As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient AccessMilken Institute's Kristin Schneeman explains how a new action plan could broaden patient access in the U.S. — and what sponsors and policymakers can do now.
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![Skin allergy diseases problem-GettyImages-1168877512]( "A Window Into Aging: Why Skin Is the First Test For RLS-1496")
A Window Into Aging: Why Skin Is the First Test For RLS-1496Rubedo’s Marco Quarta explains how patient selection, controls, biopsies, and biomarkers shaped early RLS-1496 trial protocols.
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![pharmaceuticals brazil-GettyImages-2166396884]( "Brazil's Regulatory Transformation: Building And Supporting Sites Beyond The AMCs")
Brazil's Regulatory Transformation: Building And Supporting Sites Beyond The AMCsOur expert chat about Brazil’s clinical research transformation concludes with SBOC President-elect Fabio Franke, who explores building sustainable trial capacity beyond the country’s major AMCs.
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![Health, healthcare, medicine and pharmacy in Brazil-GettyImages-1029325380]( "Brazil's Regulatory Transformation: Expanding Clinical Trial Participation")
Brazil's Regulatory Transformation: Expanding Clinical Trial ParticipationA discussion of Brazil’s clinical research transformation continues as this Q&A series turns to Maiko L. Tonini, Ph.D., of Brazil’s Ministry of Health, to explore expanding clinical trial participation.
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![brazil flag, tablet, healthcare-GettyImages-942793822]( "Brazil's Regulatory Transformation: A New Era For Clinical Development")
Brazil's Regulatory Transformation: A New Era For Clinical DevelopmentBrazil’s clinical research transformation takes center stage as this new Q&A series opens with Interfarma CEO and former ANVISA director Renato Porto.
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![AI vs human-GettyImages-2285304527]( "The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI")
The Real Problem In Patient Recruitment… Is Knowing How And When To Use AIAI might find patients faster, but only people earn their trust. A site COO explains how to pair AI speed with human judgment, plus the guardrails every site should build in.
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![FDA-GettyImages-2271237562]( "An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?")
An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?
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![hurdles-GettyImages-2163832531]( "Overcome The 6 Most Common Hurdles To Turning Wearable Data Into Usable RWE")
Overcome The 6 Most Common Hurdles To Turning Wearable Data Into Usable RWEWearable data is easy to collect but difficult to turn into trusted RWE. Explore six fixes for the most common data problems when using wearables in research.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-635978124 research computer]( "Eliminate Clinical Trial White Space With The Right AI Strategy")
Eliminate Clinical Trial White Space With The Right AI StrategyLearn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.
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Flying On Two Wings: Balancing Local Agility And Global Quality In China8/12/2026
As China expands its role in drug development, injectable therapy programs face new demands. Learn how manufacturers are scaling quality, devices, and production for global success.
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RWD, New Technologies Show Potential In Clinical Trial Recruitment7/10/2025
Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.
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The Next Era Of eCOA Is AI4/15/2026
Discover how AI is moving beyond the hype to streamline clinical study builds. Explore practical ways to automate protocol digitization and UAT scripts while preparing for future patient tools.
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De-Risking The Neurology IND: Lessons From Early FDA Engagement5/27/2026
Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.
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Sickle Cell Cure Within Reach, But At A Steep Cost7/10/2025
Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Relieving Pressure During Preparation Of A High-Volume sNDA5/27/2026
Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.
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Duchenne Muscular Dystrophy Trial In China9/17/2025
A global sponsor conducting a Duchenne Muscular Dystrophy trial in China required reliable patient travel solutions to support children and families.
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Streamlining Pediatric Clinical Trials With Vestigo®5/8/2026
Utilizing a centralized, automated platform can eliminate the friction of manual accountability logs, ensuring audit readiness while providing real-time visibility into financial reporting.
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Urgent Compliance Recovery Following Vendor Transition5/26/2026
Strong local leadership, clear ownership, and governed oversight drove rapid remediation of legacy safety gaps, restoring regulatory confidence and safeguarding market continuity.
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Solutions To The Challenges Of Oncology Trials5/6/2025
This significant Phase III trial, one of the largest global studies in head and neck cancer, faced considerable challenges including enrollment delays and an intricate study design.
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Inspection Facilitation Without Local MAH Presence5/26/2026
Local expertise and centralized oversight ensured compliant, well‑coordinated inspections across countries, reducing operational risk and client burden while maintaining consistent authority engagement.
NEWSLETTER ARCHIVE
RECRUITMENT AND DIVERSITY
This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.
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![Woman looking at the trees-GettyImages-1449632739]( "Lupus Researchers Now Have A Three-Pillar RWD Platform To Support Discovery And Development")
Lupus Nexus unites a registry, biorepository, and data exchange to give researchers longitudinal real-world data without building the infrastructure from scratch.
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![US map healthcare icons-GettyImages-522620544]( "As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient Access")
Milken Institute's Kristin Schneeman explains how a new action plan could broaden patient access in the U.S. — and what sponsors and policymakers can do now.
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![AI vs human-GettyImages-2285304527]( "The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI")
AI might find patients faster, but only people earn their trust. A site COO explains how to pair AI speed with human judgment, plus the guardrails every site should build in.
FOCUS ON PATIENTS
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![US map healthcare icons-GettyImages-522620544]( "As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient Access")
Milken Institute's Kristin Schneeman explains how a new action plan could broaden patient access in the U.S. — and what sponsors and policymakers can do now.
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![Doctor using tablet in hospital-GettyImages-2227564671]( "What Happens When Clinical Trial Patients Need Care Outside Of The Study?")
Clinical trial patients may need care outside of the trial protocol. Discover how closing information gaps can protect safety, trial participation, and data integrity.
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![Patient ultrasound examination-GettyImages-1473904792]( "Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care")
Can early APG-157 treatment control head and neck cancer without delaying curative care? A Phase 3 trial puts timing, safety, and outcomes to the test.
EDITORIAL COLLECTIONS
Take a deep dive into the issues shaping clinical research today with our curated Editorial Collections. Each collection features expert insights and practical strategies addressing today’s biggest challenges in clinical trial planning and execution.
More Editorial Collections
