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.
- When To Build Out Your ClinOps Team — And Other Advice For First-Time Biotechs
- What Happens When Clinical Trial Patients Need Care Outside Of The Study?
- 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-1316437398-planning-strategy-data]( "Phase 1 Clinical Trial Designs And Strategies")
Phase 1 Clinical Trial Designs And StrategiesWith tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
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Bringing Clinical Trials To Everyone's Backyard1/10/2025
Learn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
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eSource Purpose Is Not Just To Complete The EDC7/7/2025
Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.
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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.
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Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?10/20/2025
Noncompliance with clinical trial disclosure regulations can jeopardize M&A deals. Understanding FDA and SEC requirements is critical to avoid red flags during due diligence.
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The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event Detection11/7/2025
A proven, AI-powered safety platform can accelerate adverse event detection and safety data extraction to ease the burden on safety professionals and better protect patients.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
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How Compassion Shaped This Pediatric Rare Disease Trial6/11/2025
Learn how kindness transformed the clinical trial experience for pediatric rare disease participants in a global study.
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Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration5/27/2026
Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.
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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.
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Supporting Participants Through National Travel Disruptions12/10/2025
A sudden travel shutdown threatened a critical clinical visit. Rapid rescheduling, coordinated logistics, and clear communication ensured engagement and the ability to continue without interruption.
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CRO Uses CRIO eSource To Double Monitoring Productivity1/31/2025
Examine the transformative impact of eSource technology on monitoring productivity during a global Phase 3 trial conducted by a Contract Research Organization (CRO) amid the COVID-19 pandemic.
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
