A 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.
- 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.
- What Happens When Clinical Trial Patients Need Care Outside Of The Study?
- When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs
- Ossium's Unconventional Site Strategy For Studying A Novel Bone Marrow Donor Source
GUEST COLUMNISTS
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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.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1493505702 data]( "Futureproofing Post-Approval Compliance")
Futureproofing Post-Approval ComplianceIn the post-approval stage, a synergistic operating model brings PV and regulatory functions under one umbrella: a single governance structure with shared decision cycles, templates, and evidence.
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Overcoming Obesity Trial's Patient Engagement And Retention Challenges8/8/2026
Extended obesity trials often face high dropout rates due to fatigue and strict protocols. Learn how personalized engagement and strong care relationships improve participant retention.
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Sickle Cell Cure Within Reach, But At A Steep Cost7/10/2025
Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.
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Collaborate To Improve The Patient Experience8/8/2026
Fragmented trial operations trigger costly enrollment delays. Discover how operational alignment among sponsors, CROs, and site networks drives patient retention and study success.
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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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Transforming Effective Patient Recruitment Within The Changing Health Care Landscape2/6/2026
Revolutionize patient enrollment by closing the "95% gap." Explore an approach that uses digital health and data-driven insights to engage diverse populations where they live.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How Sponsors Can Leverage New Technologies To Lower Trial Costs1/6/2025
This study introduces sponsors to an innovative, lean, and efficient approach to data management that integrates site-facing technologies to streamline trial operations.
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Driving ROI: A Real-Time Clinical Trial Oversight Solution8/3/2026
Sample errors, delays, and query overload drain clinical trial budgets. Learn how real-time data capture can shorten timelines and protect data quality.
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Post-Market Safety And Risk Management in DMD4/11/2025
The pharmaceutical company specializing in rare neurological diseases sought solutions after encountering significant hurdles in post-market safety surveillance.
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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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Changing The Clinical Feasibility Game With AI1/22/2026
AI is only as good as the data it’s built upon. Our customized AI platforms are constructed on a foundation of trustworthy, carefully curated data to produce detailed, expert-driven responses.
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Transforming Clinical Trial Management5/5/2026
See how Vestigo® can transform your study management — streamline workflows, strengthen compliance, and eliminate inefficiencies by adopting a smarter, digital-first approach today.
NEWSLETTER ARCHIVE
- 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
- 10.30.26 -- The New Clinical Trial Regulatory Landscape Balances Speed, Quality, And Compliance — Are You Ready?
- 10.30.26 -- Services To Support Your Sites
- 10.29.26 -- Regulators Tighten Scrutiny While Too Many Vendors Strain Study Execution
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.
-
![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
