Invivyd’s Michael Mina, MD, Ph.D., discusses LIBERTY and DECLARATION, exploring how monoclonal antibodies could expand COVID-19 protection alongside vaccines.
- 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
- Brazil's Regulatory Transformation: Building And Supporting Sites Beyond The AMCs
- Brazil's Regulatory Transformation: Expanding Clinical Trial Participation
GUEST COLUMNISTS
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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.
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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.
CLINICAL TRIAL WHITE PAPERS
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![Pharmaceutical-regulations-GettyImages-1423114910]( "Navigating The European Market's Regulatory Complexities")
Navigating The European Market's Regulatory ComplexitiesPrepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.
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Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps7/7/2025
Modernizing symptom monitoring is essential to improving clinical trial quality, and these tools deliver richer, more accurate data that can help close information gaps.
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4 New Approvals In Q3 Across Gene, Cell, RNA Therapies11/13/2025
Q3 2025 brought notable progress across the gene, cell, and RNA therapy landscape, marked by four new global approvals. While regulatory progress continued, clinical development activity slowed.
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A Practical Guide To Harnessing The Value Of APAC For Global Trial Success8/21/2026
As Phase III costs and complexity rise, APAC offers faster enrollment, lower costs, and market access advantages, but capturing that value requires early planning and in-region expertise.
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The Renaissance Of Psychedelic Research: History, Protocols, And Forward Trajectories7/30/2026
Discover how clinical trial protocols are evolving to address unblinding, therapeutic support variables, and regulatory standards in modern psychedelic research.
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Gene Therapies For Rare Diseases: Platforms, Modalities, And Delivery Systems10/6/2025
Examine the treatment landscape for rare diseases and the rapid evolution of gene therapy across three key dimensions: editing platforms, delivery modalities, and delivery vehicles.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Expanding Diabetes-Related Eye Health Equity1/29/2025
20/20 Onsite, American Diabetes Association and Genentech collaborated on an event to provide immediate diagnostic services, including retinal imaging and visual acuity assessments, directly on-site.
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How eSource Reduced Benchmark's Protocol Deviations By Almost 40%1/6/2025
Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.
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Supporting Participants Through National Travel Disruptions12/10/2025
A sudden travel shutdown threatened a critical clinical visit. Rapid rescheduling, coordinated logistics, and clear communication ensured engagement and the ability to continue without interruption.
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Retaining Patients For 13+ Years In DIAD Research8/14/2026
Discover how home-based research models can improve accessibility, reduce participant burden, and help sustain engagement over many years, supporting stronger outcomes in longitudinal clinical studies.
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Launching A Unified Global Sales Team In 90 Days11/7/2025
A global CRO united 300+ sales and executive leaders across five continents for a dynamic, space-themed meeting that strengthened culture, deepened product understanding, and inspired alignment toward annual growth goals.
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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.
NEWSLETTER ARCHIVE
- 11.10.26 -- AI Saved Time. Employees Didn't Feel It.
- 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
- 11.07.26 -- Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?
- 11.06.26 -- Freeing Trial Data Without Losing Trust: AI, Precision Medicine, And Oncology Speed
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
