Lupus Nexus unites a registry, biorepository, and data exchange to give researchers longitudinal real-world data without building the infrastructure from scratch.
- 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
- 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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![eCOA-clinical-GettyImages-1331758896]( "The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials More")
The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials MoreHigh-end technology cannot fix poor rater preparation or complex patient needs. True data integrity requires bridging the gap between digital platforms and the reality of clinical implementation.
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Five Ways Centralized Trial Finance Improves Site And Patient Satisfaction6/15/2026
Centralizing payments and logistics improves transparency, accelerates reimbursements, and supports better site performance and patient retention in clinical trials.
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Overcome Patient-Level Access Barriers For New Medicine3/23/2026
Explore market access from the patient’s perspective and identify five aspects of how people get hold of medicine that should inform commercialization.
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Addressing Trial Design Hurdles Across Alzheimer's Disease Stages12/10/2025
Explore how endpoint selection, rater training, and the strategic implementation of eCOA can help address the unique scientific, operational, and human considerations at each stage of AD.
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A Guide to Digital Endpoints in Respiratory Diseases4/15/2025
Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
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The Rapid Digitization Of Trials11/7/2024
It’s no secret that more trials are going digital. Hear from a panel of industry experts including Sanofi, Bayer, and the Clinical Trials Transformation Initiative (CTTI) as they discuss the evolution of digital trials and share their experiences.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
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Use Case: A Patient-Centric Approach To Site Selection1/27/2025
Discover how Citeline’s robust datasets, combined with real-world data, inform intelligent site and investigator selection for a rare, autoimmune disease.
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Migrating A Live Personalized Medicine Trial To Next-Gen RTSM3/26/2026
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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Sleep Assessment In Sleep Disorders3/16/2026
Discover how continuous, objective monitoring in a home environment captures sleep improvements that traditional lab-based snapshots often miss, ensuring more accurate clinical outcomes.
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Streamlining A Complex Phase 2 RTSM Build10/29/2026
A complex Phase 2 trial with blinded and open-label paths needed its randomization system fast. See how smart defaults cut sponsor review work and protected the first-patient date.
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Incorrect Clinical Trial Enrollment Is Preventable. A Tale Of Three Case Studies6/5/2026
See how three clinical trials used centralized eligibility review to accelerate enrollment, eliminate enrollment-based protocol deviations, and keep studies on track, even at a global scale.
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
