Part one of this two-part series explores how clinical trial regulation aims to balance speed, quality, compliance, and digital innovation.
- The U.S. Clinical Trial Recruiting Pipeline – September 2026
- Unlocking AI Value For Clinical Research Associates
- Your EDC Query Count Is Trying To Tell You Something
- What I Heard When I Crashed Three ING Dive Teams
- Can A Universal Health Screening Help Stop Clinical Trial Dropouts?
- Can Your Team Coordinate The CRO Model You've Chosen?
- To Pick The Right Medical LLM, First Assess Your Readiness
GUEST COLUMNISTS
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Can Your Team Coordinate The CRO Model You've Chosen?
Choosing the right CRO model matters less than a sponsor’s ability to coordinate it. Here’s how to match outsourcing strategy to internal capacity.
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To Pick The Right Medical LLM, First Assess Your Readiness
Learn how to evaluate medical LLMs for clinical trials by weighing readiness, risk, validation, integration, hidden costs, and supplier controls.
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Your Company Needs Compliance Expertise — But When And From Whom?
When should a biotech formalize compliance? Learn how risk, funding, clinical activity, and commercialization shape the right expertise and structure.
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5 Sponsor Contracting Issues That Delay Clinical Trials — And How To Avoid Them
CTA negotiations don’t have to stall study start-up. Learn five sponsor-side contracting issues that cause delays and practical ways to prevent them.
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Participant Payment — Make It Make Cents
Participant payment practices and expectations vary wildly. With advocate T.J. Sharpe, explore why sponsors need to rethink how they appreciate participants' time, effort, and burden.
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What Ecological Momentary Assessment Taught Us About Real-World Hearing Outcomes
Ecological momentary assessment (EMA) reveals how people experience hearing challenges beyond the clinic. Here, researchers highlight its relevance in designing real-world hearing studies.
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Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System
Calidi’s Eric Poma, Ph.D., explains how CLD-401 could evade immune clearance — and how the biotech is designing Phase 1 to prove safety and efficacy fast.
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New Imaging Approach Could Improve IPF Trial Design
AI-powered quantitative CT could help sponsors detect treatment effects earlier, strengthen IPF trial endpoints, and make better go/no-go decisions.
CLINICAL TRIAL WHITE PAPERS
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The Evolving Landscape Of Emerging Biopharma: Modern Trends And Flexible Trial Designs
Running complex trials on a lean budget? See how adaptive designs, decentralized models, and early real-world evidence help emerging drug developers plan globally and get therapies to patients faster.
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Immunohistochemistry In Precision Medicine: From Biomarker To Clinical Trial Assay6/17/2025
From preclinical validation to clinical implementation, immunohistochemistry (IHC) is essential in understanding target biology and ensuring drug safety and efficacy.
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Automated Evidence Generation For Regulatory-Grade RWD10/20/2025
Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.
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Global Trial Disclosure Landscape Grows Increasingly Complex4/15/2025
The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.
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De-Risking The Neurology IND: Lessons From Early FDA Engagement5/27/2026
Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.
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Busy Quarter For Gene, Cell, RNA Therapies7/21/2026
Explore how Q2 brought renewed momentum for gene, cell, and RNA therapies and grew confidence in the future of advanced medicine with rising approvals, expanding pipelines, and increased investment.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Optimizing Wearable Adherence In A Phase 3 Oncology Trial5/15/2026
Long-term wearable monitoring only works if patients keep wearing the device, and in oncology trials, that’s easier said than done.
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Executing A Complex Global Breast Cancer Trial In A Rapidly Evolving Treatment Landscape9/14/2026
See how rapid site activation, strong oncology site relationships, and adaptive protocol management kept a complex global cancer trial on track amid evolving standards of care.
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Paperless Online Remote Source Document Verification2/2/2026
Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.
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Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer11/17/2025
Choose a development partner who can navigate global execution, ADC-specific challenges, and Project Optimus requirements so your first-in-human study is designed and positioned for success.
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Accelerating CRO Study Deployment At Scale7/7/2025
A top-3 CRO and a top-10 pharmaceutical company partnered with Medable to help accelerate, scale, and standardize their eCOA trials. See how they accomplished it.
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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.
NEWSLETTER ARCHIVE
- 10.19.26 -- Autoimmune Drugs For Women: What To Bring To The Clinic
- 10.16.26 -- Turning Data Into Decisions: Smarter Tools For Faster, Stronger Trials
- 10.16.26 -- Ditch Paper Binders, Scale Central Labs, And Stay Compliant Across Global Markets
- 10.15.26 -- How Can You Be Sure You Found The Right CRO Partner?
- 10.14.26 -- Can We Make Feasibility More Realistic?
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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Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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Participant payment practices and expectations vary wildly. With advocate T.J. Sharpe, explore why sponsors need to rethink how they appreciate participants' time, effort, and burden.
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Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
FOCUS ON PATIENTS
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Psychedelic-assisted treatment may offer faster, lasting relief for cancer patients facing adjustment disorder, depression, and anxiety.
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Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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Participant payment practices and expectations vary wildly. With advocate T.J. Sharpe, explore why sponsors need to rethink how they appreciate participants' time, effort, and burden.