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-2217505892-AI-artificial-intelligence]( "A New, AI-Augmented Horizon For Safety And Pharmacovigilance")
A New, AI-Augmented Horizon For Safety And PharmacovigilanceIs your organization leveraging AI to maximize efficiency in safety and regulatory workflows? If not, explore how these technologies are slated to improve industry approaches in 2026.
-
Faster Starts, Stronger Finish: Operational Excellence In NSCLC5/22/2026
In NSCLC trials, data‑driven site selection, streamlined protocols, efficient screening strategies, and proactive engagement can accelerate enrollment and improve trial efficiency across regions.
-
Developing Next-Generation Therapies For Breast Cancer Patients9/8/2026
Breast cancer trials span multiple subtypes and modalities. Learn how specialized oncology experience helps reduce enrollment risk and keep programs on track.
-
If Data Integrity Matters, Paper Is Not An Option3/5/2026
Ditch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.
-
State Of Clinical Trial Technology: The AI Inflection Point2/12/2026
Digital maturity gaps are widening in clinical research. Connected workflows speed insights and execution, while manual processes leave organizations increasingly behind.
-
Disclosure Management System: Build Or Buy?6/19/2025
Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Navigating Choppy Waters: Rapid Study Completion For An Anti-Nausea Compound7/17/2026
See how strategic technology reuse and real-time query resolution allow study teams to successfully manage high-volume, rapid participant enrollment without compromising data quality.
-
Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology5/2/2025
Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.
-
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.
-
Accelerating Recruitment In A Challenging Phase III Rare Disease Trial8/18/2026
Recruiting for rare acute diseases is challenging. Discover how this organization used rapid site activation and investigator engagement to speed enrollment in a Phase III Anti-GBM trial.
-
Streamlining Pediatric Clinical Trials With Vestigo®5/8/2026
Utilizing a centralized, automated platform can eliminate the friction of manual accountability logs, ensuring audit readiness while providing real-time visibility into financial reporting.
-
Urgent Compliance Recovery Following Vendor Transition5/26/2026
Strong local leadership, clear ownership, and governed oversight drove rapid remediation of legacy safety gaps, restoring regulatory confidence and safeguarding market continuity.
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
