Discover how well AI fared in document generation, patient engagement, data integration, and more in an end-to-end proof-of-concept study run by i-Cubed.
- How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis Suppurativa
- Unicycive Therapeutics' Framework For Speedier Clinical Trials
- Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive Disorder
- Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials
- RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short
- AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them
- Will AI And Agile Project Management Help Advance RBM?
GUEST COLUMNISTS
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![Crowd, Sale, road, promotion-GettyImages-1320971995]( "AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them")
AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join ThemAI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
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![International conflict, trade war-GettyImages-2238013885]( "Will AI And Agile Project Management Help Advance RBM?")
Will AI And Agile Project Management Help Advance RBM?Will AI-based tools embedded into risk based-monitoring prompt an Agile project management moment for clinical research? Sidharth Ananthanarayan explains why AI-based tools are not the answer but part of it.
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![pre-filled GLP-1 receptor agonist pens-GettyImages-2225780922]( "The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future")
The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized FutureThe American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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![reef knot-GettyImages-2162094857]( "Why Building Long-Term Value And Making Clinical Progress Are Inextricable")
Why Building Long-Term Value And Making Clinical Progress Are InextricableDicot Pharma CEO Elin Trampe discusses how clinical milestones, financing strategy, shareholder value, and partnering considerations must be tightly integrated in early development through late-stage planning.
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![Healthcare, public health, emergency care-GettyImages-2256438497]( "What Sponsors Don't See: The Systems Behind Clinical Trial Delivery")
What Sponsors Don't See: The Systems Behind Clinical Trial DeliveryWhat do sponsors need from sites? Easy. How do they evaluate them? Not so easy (or accurate). In this column, Association Multisite Research Corporations (AMRC) Executive Director Jim Kremidas explains how sites and sponsors can make site evaluations better.
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![Negative results, anxiety, wrong procedure-GettyImages-2215185372]( "What Really Happens At The Site When Sponsors Pull Back Mid-Trial")
What Really Happens At The Site When Sponsors Pull Back Mid-TrialWhen sponsors slow or reduce operational spending due to financial pressure, strategic pivots, or internal restructuring, sites — and patients — suffer. Curo Research CCO Amy Bland explains how sponsors can better manage operational changes.
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![AI, digital innovation-GettyImages-2202490582]( "A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI")
A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROIClinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.
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![White spheres on curved lanes over blue wall-GettyImages-1390877978]( "One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution")
One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial ExecutionHaving the same number of clinical programs as team members might sound crazy, but for Step Pharma, it has become one of their biggest strengths.
CLINICAL TRIAL WHITE PAPERS
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![Female Patient Listening to Doctor Holding Tablet-GettyImages-1947527002]( "New Duke Research Shows Participants Prefer Enhanced eConsent")
New Duke Research Shows Participants Prefer Enhanced eConsentIt’s apparent to those who have used it that the “e” in eConsent could stand for much more than 'electronic'. Duke’s new research shows why participants prefer an eConsent experience bolstered with videos, media, questions, and more.
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Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps7/7/2025
Modernizing symptom monitoring is essential to improving clinical trial quality, and these tools deliver richer, more accurate data that can help close information gaps.
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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.
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Innovating With Generative And Agentic Artificial Intelligence3/30/2026
Discover how specialized AI is revolutionizing clinical trials by enhancing data quality and operational speed through curated training, human oversight, and objective scientific analysis.
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Five Ways Centralized Trial Finance Improves Site And Patient Satisfaction6/15/2026
Centralizing payments and logistics improves transparency, accelerates reimbursements, and supports better site performance and patient retention in clinical trials.
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What Clinical Trial Decision Makers Are Prioritizing In 20255/7/2025
In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Streamlining Pediatric Clinical Trials With Vestigo®5/8/2026
Utilizing a centralized, automated platform can eliminate the friction of manual accountability logs, ensuring audit readiness while providing real-time visibility into financial reporting.
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Urgent Compliance Recovery Following Vendor Transition5/26/2026
Rapid local leadership, clear ownership of corrective actions, and governed oversight enabled time‑critical remediation of legacy safety gaps, restoring regulatory confidence and protecting market continuity under intense inspection pressure.
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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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Outgrowing Excel: Implementing RTSM In A Live Phase I Trial2/25/2026
Learn how a clinical-stage oncology biotech successfully transitioned a live Phase I trial from manual spreadsheets to RTSM without disrupting site momentum or patient enrollment.
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Reinventing Prostate Cancer Diagnostics With An All-In-One Platform3/31/2026
Discover how a lean research team saved an estimated $100k and reached 95% data compliance by unifying their clinical workflow.
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Increasing Efficiency And Reducing Drug Waste10/2/2025
Discover how streamlined clinical supply chain management helped accelerate study timelines, reduce costs, and support global treatment delivery through a strategic technology partnership.
NEWSLETTER ARCHIVE
- 07.03.26 -- Optimize Your Trial Data Journey
- 07.03.26 -- Maximizing Pipeline Value: From Portfolio Optimization To Early-Phase Efficiency
- 07.02.26 -- What Happens When Sponsors Pull Back Mid-Trial?
- 07.01.26 -- Bridging Community And Central Hospitals With Japan's DCT Model
- 07.01.26 -- STREAM Edition: What's Moving Clinical Research Forward: AI, RWE, And Trial Innovation
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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![Crowd, Sale, road, promotion-GettyImages-1320971995]( "AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them")
AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
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![child getting vaccine-GettyImages-1678122790]( "Lessons In Pivoting From A Clinical Trial Launch In Uganda")
Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
FOCUS ON PATIENTS
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![pre-filled GLP-1 receptor agonist pens-GettyImages-2225780922]( "The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future")
The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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![Blue Print-GettyImages-172211936]( "A Blueprint For Addressing Underserved Patient Populations")
Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.
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![Disability, daily activities-GettyImages-2169336772]( "New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA")
NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.
