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-1068004492 women]( "Decentralized And Community-Based Solutions Driving Women's Healthcare")
Decentralized And Community-Based Solutions Driving Women's HealthcareClinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
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Breaking Through Barriers With Integrated Trial Optimization5/9/2025
In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.
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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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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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Agentic AI And How It's Impacting Clinical Trial Research7/7/2025
Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
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Meeting The FDA's New Real-World Evidence Standards5/27/2026
FDA guidance is reshaping RWE strategy. Sponsors that build interoperable, audit-ready RWD infrastructure now will be best positioned for faster, defensible submissions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How Expert Medical Information Support Strengthened A Rare Respiratory Therapy Launch5/26/2026
Embedded medical information expertise enabled compliant, real‑time scientific engagement with healthcare professionals at a high‑profile congress during a critical product launch.
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Turning Urgency Into Progress And Advancing New Hope In AML9/22/2026
A disrupted AML trial stabilized mid-study, cutting genetic testing turnaround to 1–2 days and keeping enrollment on track for patients who can't wait.
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Rescuing A Global Program For NDA Success8/12/2025
Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.
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Breaking Free From Process Paralysis In Clinical Trials1/13/2025
Explore the implementation of CRIO’s eSource solution by a leading pharmaceutical company to overcome process paralysis in clinical research.
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Successful Partnership Advances AML Program To Phase II/III10/26/2026
See how strong collaboration rescued a stalled AML study, proved a safer approach to a proven drug class, and turned a Phase I/II partnership into a global Phase II/III trial.
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How eSource Reduced Benchmark's Protocol Deviations By Almost 40%1/6/2025
Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.
NEWSLETTER ARCHIVE
- 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
- 10.28.26 -- The U.S. Clinical Trial Recruiting Pipeline – September 2026
- 10.28.26 -- Feasibility Isn't Just A Technology Problem
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
