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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![GettyImages-525755915 clinical team eCOA]( "The Strategic Advantage Of eCOA And IRT")
The Strategic Advantage Of eCOA And IRTThe future lies in unified, interoperable eCOA–IRT solutions that streamline operations, improve data integrity, and enhance patient and site experience.
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Addressing Trial Design Hurdles Across Alzheimer’s Disease Stages12/10/2025
Explore how endpoint selection, rater training, and the strategic implementation of eCOA can help address the unique scientific, operational, and human considerations at each stage of AD.
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Pharma R&D Annual Review Supplement: New Active Substances4/15/2026
Last year was by some distance the best year ever in terms of new active substances. Explore the 105 new debuts that easily outstrips that of the previous record holder, 2021’s, 97.
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AI-Driven Signal Management: The Future Of Drug Safety12/19/2025
By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.
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Empower Your Trial With Data And Evidence1/14/2026
Fuel your clinical development and decision-making with insights from fit-for-purpose data and evidence.
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Unlock The Power Of Clinical Data Science3/9/2026
Discover a unified, AI‑driven approach that helps clinical teams manage growing data complexity, accelerate insight generation, and improve trial oversight to enable faster decisions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Quantitative ROI With DCTs11/13/2025
Through dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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Market Approval For A Novel Non-Hodgkin Lymphoma (NHL) Therapy4/11/2025
Explore a collaboration that underscores the importance of strategic planning and regulatory engagement in the approval process.
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Automated Trial Monitoring Workflows Make A Lean Team More Efficient1/7/2026
A pharmaceutical therapy developer was looking to automate reports, confirmation letters, and follow-up letters. See what happened when they adopted a cloud-based solution for end-to-end trial management.
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AI In Clinical Data Management: How Does It Work?8/18/2024
AI is revolutionizing clinical data management by automating medical coding, data reconciliation, and audit trail reviews, significantly enhancing efficiency and accuracy.
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Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning1/31/2025
The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.
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3-Week Database Builds That Withstood FDA Review3/31/2026
Learn how a lean clinical team deployed global, regulator-ready databases in just three weeks to secure immediate Phase 3 entry and transform reproductive health research.
NEWSLETTER ARCHIVE
- 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
- 06.30.26 -- Computer Software Assurance And Its Benefits
- 06.30.26 -- Better IDS Workflows Start Here
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.
