Incannex CEO Joel Latham explains how thoughtful trial design and dose optimization can turn promising data into an approval-ready strategy.
- 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
- Brazil's Regulatory Transformation: Building And Supporting Sites Beyond The AMCs
- Brazil's Regulatory Transformation: Expanding Clinical Trial Participation
- Washington's Clinical Trial Alphabet Soup
GUEST COLUMNISTS
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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.
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![Doctor using tablet in hospital-GettyImages-2227564671]( "What Happens When Clinical Trial Patients Need Care Outside Of The Study?")
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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![Team Blocks-GettyImages-1860565143]( "When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs")
When To Build Out Your ClinOps Team — And Other Advice For First-Time BiotechsSmall biotechs shouldn't model their ClinOps headcount after Big Pharma. Instead, they need the right capabilities, oversight, and risk controls. Consultant Jessica Cordes explains.
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![OssiumHealth11]( "Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor Source")
Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor SourceOssium CEO Kevin Caldwell explains how an unconventional multisite Phase 1 trial is shaping the company's novel bone marrow product’s path ahead.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1332585814 oncology patient nurse]( "Implications Of Assessing Overall Survival In Oncology Studies")
Implications Of Assessing Overall Survival In Oncology StudiesNew oncology standards mandate pre-specified survival analysis to catch long-term harm. Learn how to implement hazard ratio thresholds and the ICH E9(R1) framework for global compliance.
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Advancing Alzheimer's Disease Therapies9/3/2025
By uniting scientific innovation with patient-focused execution, the next generation of alzheimer’s disease (AD) therapies has the potential to deliver a transformative impact on global health.
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Global Trial Disclosure Landscape Grows Increasingly Complex4/15/2025
The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.
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Redefining Vaccine Trial Recruitment8/8/2026
Modern vaccine trials demand flexible, transparent recruitment workflows. Discover strategies to overcome enrollment delays and build representative, diverse study cohorts.
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A Smartphone Based Biomarker For The Estimation Of Unipolar Depression Severity3/28/2025
The study investigates the potential of using smartphones and wearables to create objective biomarkers for mood disorders, specifically focusing on unipolar depression.
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Effectively Tailoring Treatments Based On Genetic & Molecular Profiling9/30/2026
Precision medicine is transforming hematology-oncology care by matching treatments to the distinct genetic and molecular profiles of each patient.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How A Rare Disease Biotech Replaced Manual Processes With RTSM Software3/26/2026
Discover how a clinical-stage biotech automated its supply chain to protect patient enrollment and eliminate manual errors in a complex, multi-national genetic medicine trial.
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Advancing Immunotherapy In Head And Neck Cancer: The IT-MATTERS Study4/17/2025
This randomized controlled pivotal Phase 3 study evaluated efficacy and safety of neoadjuvant complex biologic administered for three consecutive weeks pre-surgery.
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Accelerating Approval Pathway For Phase III Ovarian Cancer Trial8/29/2025
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
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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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Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan2/7/2025
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
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Guiding GLP-1 Participants Through The Challenge Of Retention12/4/2025
Learn how remote lifestyle coaching can combat high dropout rates in metabolic research by offering the support participants need to maintain adherence and ensure data integrity.
NEWSLETTER ARCHIVE
- 11.09.26 -- The Site Landscape Is Evolving, But How?
- 11.09.26 -- Cancer Trial Recruitment Isn't Failing On Eligibility — It's Failing On Trust
- 11.06.26 -- Freeing Trial Data Without Losing Trust: AI, Precision Medicine, And Oncology Speed
- 11.06.26 -- Protect First-Patient Dates, Tighten Supply Oversight, And Stay Inspection-Ready
- 11.05.26 -- When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs
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
