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
-
![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?
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
-
![GettyImages-1208552262 elderly, patient, telehealth]( "Offline eCOA: The Real-Time Monitoring Dilemma")
Offline eCOA: The Real-Time Monitoring DilemmaBalance the need for offline data safety with the necessity of real-time monitoring. Learn how to navigate new regulatory requirements for source devices while maintaining high patient compliance.
-
A Smartphone Based Biomarker For The Estimation Of Unipolar Depression Severity3/28/2025
The study investigates the potential of using smartphones and wearables to create objective biomarkers for mood disorders, specifically focusing on unipolar depression.
-
Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
-
Eliminate Clinical Trial White Space With The Right AI Strategy10/9/2025
Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.
-
The True ROI Of Decentralized Clinical Trials11/13/2025
Gain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
-
Challenges, Opportunities For Recruitment In The Digital Age10/20/2025
Health literacy gaps and online misinformation hinder clinical trial recruitment. Meeting patients where they are — digitally and educationally — can improve engagement and enrollment success.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
GSK And Medable Discuss The Next Phase Of DCTs3/10/2025
GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.
-
Powering Complex Personalized Medicine Oncology Trial2/25/2026
Managing custom therapies requires a synchronized supply chain. Learn how to bridge the gap between manufacturing and clinical workflows to ensure seamless patient care in complex oncology trials.
-
Delivering Specialist Neurology Support4/17/2025
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
-
Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments2/3/2025
A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
-
Data Key In Addressing Patient Recruitment Challenges6/19/2025
Explore how a Phase II trial for extensive-stage and previously treated small cell lung cancer overcame recruitment challenges with a data-driven solution designed to surface protocol-matched patients.
-
Enhance Access And Improve Retention In Rare Disease Trials With HTS4/17/2025
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
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.
-
![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?
-
![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.
-
![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
-
![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.
-
![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.
-
![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.
