Recruitment problems can start long before actual recruitment. Who is making sure your team gets ahead of those challenges?
- Two Parallel Trials, A Potential New Option For Protection From COVID-19
- 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
GUEST COLUMNISTS
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![business mountain route growth achievement-GettyImages-2295932352]( "Novel Science, Familiar Regulatory Pathways: Inside Tonix's Clinical Development Strategy")
Novel Science, Familiar Regulatory Pathways: Inside Tonix's Clinical Development StrategyTonix CEO Seth Lederman, MD, explains how the company pairs novel science with proven regulatory paths across fibromyalgia, depression, and Lyme disease.
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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?
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1146439597 data, research, tablet]( "The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event Detection")
The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event DetectionA proven, AI-powered safety platform can accelerate adverse event detection and safety data extraction to ease the burden on safety professionals and better protect patients.
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Innovating With Generative And Agentic Artificial Intelligence3/30/2026
Discover how specialized AI is revolutionizing clinical trials by enhancing data quality and operational speed through curated training, human oversight, and objective scientific analysis.
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Selecting A Central Lab Network For Radiopharmaceutical Readiness9/29/2026
A wave of late-stage radiopharmaceutical trials is straining lab infrastructure concentrated in a handful of academic centers, limiting site diversity, expertise, and trial capacity nationwide.
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Go From Three Meetings To One With AI-Enabled eCOA5/5/2026
Learn how to turn three meetings into one with AI that is streamlining clinical workflows by reducing redundant steps, simplifying site operations, and accelerating data collection.
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Wearables For Optical Cardiovascular Monitoring6/10/2025
Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).
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Tracking Functional Capacity To Advance Neuromuscular Disease Research2/6/2026
This presentation introduces a dual-endpoint approach to monitoring neuromuscular disease progression through two high-centile digital measures.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology5/2/2025
Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.
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Outgrowing Excel: Implementing RTSM In A Live Phase I Trial2/25/2026
Learn how a clinical-stage oncology biotech successfully transitioned a live Phase I trial from manual spreadsheets to RTSM without disrupting site momentum or patient enrollment.
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Recruiting & Retaining More Patients Per Site:3/14/2025
Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
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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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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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Biotech Delivers A Superior Patient And Site Experience3/4/2025
To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.
NEWSLETTER ARCHIVE
- 11.13.26 -- Fewer Data Silos, Sharper Dose Decisions, Shared Site Intel: What Trial Teams Want Now
- 11.13.26 -- Partnering Across The Pipeline: Early Oncology To Ultra-Rare Approvals
- 11.12.26 -- Vendor Disruption, Dropout Risk, And What's Really Threatening Trial Timelines
- 11.11.26 -- Running Decentralized Trials At Scale
- 11.11.26 -- Helping Staff Execute Clinical Trials
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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![Hat on a hook-GettyImages-2149110150]( "Who's Wearing The Patient Recruitment Hat When Your Trial Decisions Are Made?")
Recruitment problems can start long before actual recruitment. Who is making sure your team gets ahead of those challenges?
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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.
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
