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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![predictive medical analytics, digital AI interface, patient data, DNA insights-GettyImages-2262212753]( "Phase-Appropriate Signal Detection In Clinical Trials")
Phase-Appropriate Signal Detection In Clinical TrialsAre your trial safety methods right for your phase? Learn a framework that keeps medical judgment central, avoids overreading sparse early data and catches rarer risks as studies grow.
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The Patient Experience Paradox: eCOA Strategy Overhaul3/25/2026
European regulatory shifts now require the systematic integration of patient data. Success depends on aligning clinical and market access strategies through rigorous evidence generation.
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Retention Begins With Recruiting The Right-Fit Patients11/13/2025
Recruiting the right patients into a clinical trial is only half the battle. To combat attrition, sponsors must also institute measures that ensure patients remain comfortable and confident throughout the trial.
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The Real Cost In CNS Trials: Rater Drift And Site Readiness11/21/2025
Learn how to build resilience into CNS trial operations with evidence-based frameworks that prioritize human factors alongside digital tools.
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10 Clinical Research Practices That Feel Like Compliance (But Aren't)3/24/2026
Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
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The Evolving Landscape Of Emerging Biopharma: Modern Trends And Flexible Trial Designs9/28/2026
Running complex trials on a lean budget? See how adaptive designs, decentralized models, and early real-world evidence help emerging drug developers plan globally and get therapies to patients faster.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Use Case: How Consulting & Analytics Can Guide Clinical Strategy7/10/2025
A large European pharmaceutical company sought to benchmark a CRO’s suggestions involving a Phase III trial for a newly acquired asset.
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GSK And Medable Discuss The Next Phase Of DCTs3/10/2025
GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.
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How A Leading Chinese Biopharmaceutical Company Modernized Clinical Operations7/15/2026
A growing biopharma pipeline needed better document oversight. Learn how automation and centralized tracking improved compliance and trial visibility.
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Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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Overcoming Unexpected Obstacles In A Phase 1 Study1/29/2025
Discover how the implementation of mobile vision clinics (MVCs) was used to enhance efficiency in a Phase 1 clinical trial.
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NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission8/12/2025
A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).
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
