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
- The 2026 Pharma R&D AI Sourcing Map: Partnerships, Concentration, Inflection
- Firsthand Findings: How Incannex Is Designing Trials That Support Regulatory Approval
- Lupus Researchers Now Have A Three-Pillar RWD Platform To Support Discovery And Development
- As U.S. Trial Share Slips, A Coalition Maps A Path To Broader Patient Access
- Novel Science, Familiar Regulatory Pathways: Inside Tonix's Clinical Development Strategy
- A Window Into Aging: Why Skin Is the First Test For RLS-1496
GUEST COLUMNISTS
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
-
![GettyImages-1316791903-doctor-with-tablet-in-office-hand]( "A New Approach To Dynamic Clinical Oversight With Centralized Insights")
A New Approach To Dynamic Clinical Oversight With Centralized InsightsRBQM is transforming clinical trial oversight. By automating protocol digitalization, site selection, and risk assessments 360° Monitoring enables the proactive identification of CtQ factors.
-
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.
-
What Is ICH GCP, And How Does It Impact Clinical Planning?10/20/2025
The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.
-
Agentic AI And How It's Impacting Clinical Trial Research7/7/2025
Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
-
Navigating The U.S. Healthcare System: Coverage, Costs, And Reimbursement4/29/2026
A clear guide to U.S. coverage, regulation, and reimbursement: who decides care, how products gain access, and how policy and financing shape cost, value, and patient access.
-
Global e-Consent Matrix3/9/2026
Navigate complex regional regulations and identity requirements to modernize your global clinical trial enrollment. Ensure compliance and access while moving toward digital participant engagement.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
How A Biotech Startup Transformed Its Clinical Trial Supply Management2/25/2026
Don’t let your trial get lost in the shuffle of legacy vendors. See how a high-touch, consultative approach can protect your study’s future.
-
Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays9/25/2025
Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
-
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.
-
Expanding Access To Post-Market Safety Exams For Cystic Fibrosis Medication1/29/2025
This study highlights the transformative impact of point-of-need care on patient access, focusing on pediatric cystic fibrosis (CF) patients requiring essential eye exams.
-
A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
-
Building A Scalable Oncology Engine In A Dynamic Market6/3/2026
Learn how a top-10 global pharmaceutical company partnered with Medable to rapidly scale the number of oncology trials it could concurrently conduct.
NEWSLETTER ARCHIVE
- 11.14.26 -- Best Of October
- 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
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.
-
![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?
-
![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.
-
![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
-
![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.
-
![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.
-
![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
