Lupus Nexus unites a registry, biorepository, and data exchange to give researchers longitudinal real-world data without building the infrastructure from scratch.
- A Window Into Aging: Why Skin Is the First Test For RLS-1496
- Walmart's Clinical Trial Model Faces Its Real Test
- 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
- Brazil's Regulatory Transformation: A New Era For Clinical Development
- The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI
GUEST COLUMNISTS
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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.
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![privacy, data breach, cybersecurity-GettyImages-2214686070]( "Who Owns Your Clinical Trial Software When The Vendor Leaves?")
Who Owns Your Clinical Trial Software When The Vendor Leaves?When a clinical trial software vendor exits, sponsors still own the risk. Learn what to secure before signing a contract to protect data, validation, and continuity.
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![FDA Headquarters MD-GettyImages-2278014569]( "What The New PDUFA Guidance Means For Drug Development")
What The New PDUFA Guidance Means For Drug DevelopmentLearn how the FDA’s updated PDUFA meeting guidance affects sponsor engagement, preparation, and the way feedback shapes drug development.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-2179548801-ADC-3d-render]( "A New Era Of ADC Development Demands A New Kind Of Partner")
A New Era Of ADC Development Demands A New Kind Of PartnerExplore how to navigate the evolution of antibody-drug conjugates by mastering AI-driven selection, dose optimization, and new regulatory strategies for earlier-line clinical success.
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A New Blueprint For Transforming Feasibility And Recruitment9/22/2025
Discover how a connected approach links feasibility and recruitment, using real-world data to design realistic protocols, reach the right patients, and accelerate enrollment with confidence.
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Overcoming Issues Of Non-Enrolling Sites In Clinical Trials1/14/2025
Explore the challenges of non-enrolling sites in clinical trials, focusing on the benefits of leveraging artificial intelligence (AI) and machine learning (ML) in addressing those issues.
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Beyond Automation: Transforming Clinical Trial Delivery Through Structured Information10/23/2026
Study build delays stem less from slow tasks than from protocol intent being reinterpreted at every handoff. Treating the protocol as structured, reusable information changes where AI and expertise belong.
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Designing More Representative Trials Through Strategic Planning5/28/2025
Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.
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Merits Of A Multifaceted Approach To Clinical Trial Recruitment1/27/2025
The best way to address clinical trial recruitment challenges is with a multifaceted approach that goes beyond traditional channels and ways of thinking.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Breaking Down Operational And Financial Complexity In Clinical Trials12/8/2025
Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.
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GA Screening: Early Detection For Future Trial Recruitment4/9/2026
Community-based screenings identify undiagnosed eye disease at high rates, creating a scalable, high-trust pathway for early intervention and improved clinical research recruitment.
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Reframing Clinical Vendor Selection7/2/2025
Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
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Supporting Seamless Execution Across Early Phase Alzheimer's Trials7/31/2026
Enrollment hesitancy, staff turnover, and compressed timelines threatened a multi-phase Alzheimer's program. Learn the operational approach that delivered results at every stage.
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Reducing The Burden Of Patient Retention And Improving Continuity1/6/2026
Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.
NEWSLETTER ARCHIVE
- 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
- 11.04.26 -- Feasibility Isn't Just A Technology Problem
- 11.04.26 -- The "Fantasy" On Both Sides Of Feasibility
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
