Walmart and Care Access are bringing clinical trials into retail stores, but convenient locations are only part of the equation. Can this model improve recruitment, retention, and access — or simply offer a new setting for familiar research challenges?
- Brazil's Regulatory Transformation: Expanding Clinical Trial Participation
- Washington's Clinical Trial Alphabet Soup
- Brazil's Regulatory Transformation: A New Era For Clinical Development
- The Real Problem In Patient Recruitment… Is Knowing How And When To Use AI
- An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?
- Overcome The 6 Most Common Hurdles To Turning Wearable Data Into Usable RWE
- AI Saved Time. Employees Didn't Feel It.
GUEST COLUMNISTS
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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.
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![OssiumHealth11]( "Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor Source")
Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor SourceOssium CEO Kevin Caldwell explains how an unconventional multisite Phase 1 trial is shaping the company's novel bone marrow product’s path ahead.
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![privacy, data breach, cybersecurity-GettyImages-2214686070]( "Who Owns Your Clinical Trial Software When The Vendor Leaves?")
Who Owns Your Clinical Trial Software When The Vendor Leaves?When a clinical trial software vendor exits, sponsors still own the risk. Learn what to secure before signing a contract to protect data, validation, and continuity.
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![FDA Headquarters MD-GettyImages-2278014569]( "What The New PDUFA Guidance Means For Drug Development")
What The New PDUFA Guidance Means For Drug DevelopmentLearn how the FDA’s updated PDUFA meeting guidance affects sponsor engagement, preparation, and the way feedback shapes drug development.
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![Diverse women doctors-GettyImages-2246070483]( "The Site Landscape Is Evolving, But How? Tufts CSDD Shares New Findings")
The Site Landscape Is Evolving, But How? Tufts CSDD Shares New FindingsTufts CSDD data reveals how academic, independent, and network-affiliated clinical trial sites differ in growth, reach, staffing, and performance.
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![Patient ultrasound examination-GettyImages-1473904792]( "Testing Early Treatment In Head And Neck Cancer Without Compromising Curative Care")
Testing Early Treatment In Head And Neck Cancer Without Compromising Curative CareCan 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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![new reg part 1 - GettyImages-1366013071]( "The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?")
The New Clinical Trial Regulatory Landscape Balances Speed, Quality, and Compliance — Are You Ready?Part one of this two-part series explores how clinical trial regulation aims to balance speed, quality, compliance, and digital innovation.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1371925389-lab-scientist-collaboration-computer-clipboard]( "Navigating Complexity In Master Protocols With Key Operational Partners")
Navigating Complexity In Master Protocols With Key Operational PartnersComplex adaptive trials offer real efficiency gains, but success hinges on having experienced partners to manage the operational details.
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Designing More Representative Trials Through Strategic Planning5/28/2025
Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.
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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.
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Beyond The Benchmark: Innovative Trial Designs Transform Research1/15/2026
Adaptive designs, decentralized models, and AI insights are reshaping trials — boosting efficiency, speeding timelines, and strengthening evidence amid evolving regulations and funding pressures.
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Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape9/1/2025
Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.
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The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials More3/25/2026
High-end technology cannot fix poor rater preparation or complex patient needs. True data integrity requires bridging the gap between digital platforms and the reality of clinical implementation.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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.
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Delivering A Registrational GI Trial Through Ongoing Protocol Shifts10/17/2025
A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.
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When Every Hour Counts: Emergency Transfer Protects Critical Biomedical Materials8/10/2026
Rapid deployment of specialized cold chain logistics and cryogenic assets ensures strict temperature compliance, protecting critical research continuity and preventing catastrophic material loss.
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NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission8/12/2025
A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).
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Advancing Oncology Innovation With Adaptive Trial Designs8/12/2025
When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.
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Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech10/2/2025
This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.
NEWSLETTER ARCHIVE
- 11.04.26 -- Feasibility Isn't Just A Technology Problem
- 11.04.26 -- The "Fantasy" On Both Sides Of Feasibility
- 11.04.26 -- What's Shaping Healthcare Value And Access?
- 11.03.26 -- Disconnected Systems Are Costing Trials Time — Here's Where Teams Are Catching Up
- 11.02.26 -- AI Can't Fix Enrollment When Payments, Sites, And Trust Break Down
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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![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.
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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.
FOCUS ON PATIENTS
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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.
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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.
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
