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.
- 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
- Who Owns Your Clinical Trial Software When The Vendor Leaves?
- What The New PDUFA Guidance Means For Drug Development
- The Site Landscape Is Evolving, But How? Tufts CSDD Shares New Findings
GUEST COLUMNISTS
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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.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-2185301590-microscope-scientist-lab]( "Matching Pharmacovigilance Methodology To Organizational Scale")
Matching Pharmacovigilance Methodology To Organizational ScaleOne-size-fits-all doesn't work for safety signal detection. Discover a scalable framework that keeps expert judgment at the center — no matter how large your portfolio grows.
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The PMCF Decision Guide10/14/2026
Proposed EU reforms may remove standalone PMCF reporting, yet the duty to proactively collect clinical data remains. Method selection, notified body defense, and data-capture cost determine what comes next.
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Wearables For Optical Cardiovascular Monitoring6/10/2025
Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).
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Implications Of Assessing Overall Survival In Oncology Studies3/25/2026
New oncology standards mandate pre-specified survival analysis to catch long-term harm. Learn how to implement hazard ratio thresholds and the ICH E9(R1) framework for global compliance.
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What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research?1/28/2025
Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.
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Global e-Consent Matrix3/9/2026
Navigate complex regional regulations and identity requirements to modernize your global clinical trial enrollment. Ensure compliance and access while moving toward digital participant engagement.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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From Months To Hours: MMC Medical's EDC Revolution3/31/2026
Learn how a specialized CRO reduced study build times by 95%. Discover strategies for template reusability and flexible resource scaling to accelerate early-stage medical device validation.
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Leveraging A Demand-Led Clinical Supply Model For Program-Level Product Pooling3/12/2026
See how a global biopharmaceutical company was able to address inefficiencies and reduce waste within the clinical supply chain for a high-value therapy that faced strong demand but limited supply.
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No More Swiss Holes: Filling The Gaps In Clinical Trial Disclosure1/14/2026
This use case shows how sponsors can gain clarity on disclosure requirements when entering a new country.
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Study Analysis – Site Payment Automation12/8/2025
By removing administrative bottlenecks, see how automation improves cash flow for sites, reduces operational burden for sponsors, and supports smoother, more predictable trial execution.
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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.
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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.
NEWSLETTER ARCHIVE
- 10.29.26 -- Regulators Tighten Scrutiny While Too Many Vendors Strain Study Execution
- 10.28.26 -- The U.S. Clinical Trial Recruiting Pipeline – September 2026
- 10.28.26 -- Feasibility Isn't Just A Technology Problem
- 10.27.26 -- Sponsors Choosing Trial Tech Are Overlooking Important Factors
- 10.27.26 -- Helping Sponsors Advance Transparency And Regulatory Compliance
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
