Ossium CEO Kevin Caldwell explains how an unconventional multisite Phase 1 trial is shaping the company's novel bone marrow product’s path ahead.
- What The New PDUFA Guidance Means For Drug Development
- The Site Landscape Is Evolving, But How? Tufts CSDD Shares New Findings
- Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care
- Founders, Fortitude, And Clinical Trials
- Get Ready For Regulators With This Speed-Quality-Compliance Framework
- The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?
- The U.S. Clinical Trial Recruiting Pipeline – September 2026
GUEST COLUMNISTS
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![new reg part 2 - GettyImages-1366013071]( "Get Ready For Regulators With This Speed-Quality-Compliance Framework")
Get Ready For Regulators With This Speed-Quality-Compliance FrameworkPart two of a two-part series, experts Sapna Rani and Shaun Hastings offer a five-part framework to balance speed, quality, and compliance amid evolving clinical trial regulations.
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![psychology, counseling-GettyImages-2274786993]( "Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?")
Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?Psychedelic-assisted treatment may offer faster, lasting relief for cancer patients facing adjustment disorder, depression, and anxiety.
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![Lab Experiment-GettyImages-157697835]( "The U.S. Clinical Trial Recruiting Pipeline – September 2026")
The U.S. Clinical Trial Recruiting Pipeline – September 2026This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from August to September.
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![cyber security sign-GettyImages-1070773010]( "Unlocking AI Value For Clinical Research Associates")
Unlocking AI Value For Clinical Research AssociatesClinical research associates (CRAs) have largely been late to adopt AI. CRAs who adopt it can streamline repetitive work while also freeing capacity for high-judgment work.
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![Exclamation Symbol Blocks with Computer Mouse-GettyImages-2268428175]( "Your EDC Query Count Is Trying To Tell You Something")
Your EDC Query Count Is Trying To Tell You SomethingA rising EDC query count may reveal more than dirty data. Learn how query patterns can expose upstream problems in trial workflows, training, and CRF design.
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![patient and doctor analyzing medical report-GettyImages-1461330630]( "Can A Universal Health Screening Help Stop Clinical Trial Dropouts?")
Can A Universal Health Screening Help Stop Clinical Trial Dropouts?Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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![Remote work, hybrid-GettyImages-2065627473]( "Can Your Team Coordinate The CRO Model You've Chosen?")
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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![LLM, AI Large Language Model-GettyImages-2149059417]( "To Pick The Right Medical LLM, First Assess Your Readiness")
To Pick The Right Medical LLM, First Assess Your ReadinessLearn how to evaluate medical LLMs for clinical trials by weighing readiness, risk, validation, integration, hidden costs, and supplier controls.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1182436133 scientist, lab, research, oncology]( "Potential Of eClinical Solutions To The Complexity Of Oncology Trials")
Potential Of eClinical Solutions To The Complexity Of Oncology TrialsHow are eClinical technologies—specifically IRT and eCOA— being leveraged to overcome patient recruitment difficulties, high mortality rates, and the intricacies of cancer treatments.
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Why Life Science Organizations Need A Chief Patient Officer Function4/27/2026
Bridging the gap between innovation and impact, this exploration of the Chief Patient Officer role offers a strategic framework to integrate patient insights and de-risk the product lifecycle.
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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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Capital Efficiency In Cardiovascular Outcomes Trials7/8/2026
New modeling shows aligning clinical and manufacturing operations in heart trials can cut costs, speed timelines, and boost expected program value.
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A New Era Of ADC Development Demands A New Kind Of Partner3/30/2026
Explore how to navigate the evolution of antibody-drug conjugates by mastering AI-driven selection, dose optimization, and new regulatory strategies for earlier-line clinical success.
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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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.
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Partnership Driving Superior Enrollment And Speed In Phase III Trial1/31/2025
Examine the partnership between CRIO and Sitero, including how it underscores the significant impact of technology in optimizing trial performance and accelerating treatment development.
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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.
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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.
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How Syneos Health Tackles Protocol Complexities1/7/2025
Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase I-IV clinical trials, particularly under a complex adaptive trial protocol.
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Powering Complex Personalized Medicine Oncology Trial2/25/2026
Managing custom therapies requires a synchronized supply chain. Learn how to bridge the gap between manufacturing and clinical workflows to ensure seamless patient care in complex oncology trials.
NEWSLETTER ARCHIVE
- 10.23.26 -- How One Sponsor Rescued A Trial Mid-Study — Plus 6 Steps To AI-Ready Data
- 10.22.26 -- From Psychedelics To Rare Disease: Navigating Regulatory Hurdles
- 10.22.26 -- [For Biotech] Build Smarter Oncology Trials
- 10.21.26 -- Choose Your Approach: Traditional, Hybrid Or Decentralized
- 10.21.26 -- From Protocol Design To Site Workflows: Building Trials That Run Smarter
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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![patient and doctor analyzing medical report-GettyImages-1461330630]( "Can A Universal Health Screening Help Stop Clinical Trial Dropouts?")
Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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![Medicine, healthcare insurance-GettyImages-1369119541]( "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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![Mature student Studying-GettyImages-1460342076]( "Most Patients Learn About A Trial Online, But Is That What They Want?")
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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![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.
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![psychology, counseling-GettyImages-2274786993]( "Can Psychedelic‑Assisted Treatment Redefine Emotional Care In Oncology?")
Psychedelic-assisted treatment may offer faster, lasting relief for cancer patients facing adjustment disorder, depression, and anxiety.
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![patient and doctor analyzing medical report-GettyImages-1461330630]( "Can A Universal Health Screening Help Stop Clinical Trial Dropouts?")
Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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
