King’s College London Professor Maddy Parsons says AI won't improve clinical trials — unless researchers begin collecting richer biological data, embracing diversity, and treating every clinical trial as learning opportunity.
- i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They Learned
- Why "Steady Evolution" Best Describes AI's Future
- Social Media Is Replete With Patient RWD, But How Can Researchers Best Use It?
- 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
GUEST COLUMNISTS
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![Medical innovation-GettyImages-1295854799]( "Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials")
Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical TrialsLearn from ex-FDA and ELIQUENT consultant Dawn Wydner, Ph.D.., how treating data integrity as an end-to-end clinical information flow issue, rather than a database-only concern, is essential to managing AI-related risk.
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![EMR, Electronic medical record-GettyImages-917611012]( "RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short")
RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall ShortChiesi's Rachele Berria, MD, Ph.D., discusses how RWE is reshaping rare disease drug development strategies, from leveraging registries and patient-reported outcomes to navigating evolving regulatory expectations.
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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.
CLINICAL TRIAL WHITE PAPERS
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![Close up on eyes GettyImages-1207244495]( "What Re-Acquisition In Retinal Imaging Is Really Costing Your Program")
What Re-Acquisition In Retinal Imaging Is Really Costing Your ProgramHigh screen failure rates and patient dropout often stem from preventable imaging errors. Learn how proactive quality control and patient-centric logistics secure critical retinal trial data.
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Beyond The Benchmark: Innovative Trial Designs Transform Research1/15/2026
Adaptive designs, decentralized models, and AI insights are reshaping trials — boosting efficiency, speeding timelines, and strengthening evidence amid evolving regulations and funding pressures.
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A New Approach To Dynamic Clinical Oversight With Centralized Insights7/10/2025
RBQM is transforming clinical trial oversight. By automating protocol digitalization, site selection, and risk assessments 360° Monitoring enables the proactive identification of CtQ factors.
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Completed Clinical Trials Continued To Climb In 20246/19/2025
Data collected in this report reflects a shift toward sustained growth, reflecting rapid advancement in therapeutic areas such as oncology, autoimmune/inflammation, and central nervous system studies.
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Real-Time Clinical Data Insights Delivered By Automation And AI2/26/2026
Automated data flows and human‑guided AI enable faster, more reliable oversight into clinical trials. Learn how real‑time insights and unified monitoring support quality, efficiency, and readiness.
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eSource Purpose Is Not Just To Complete The EDC7/7/2025
Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Reserving Data Integrity With Retrospective Manual Entry7/5/2026
A look at implementing randomization mid-trial by reconstructing subject and inventory records without disrupting sites or compromising data integrity.
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Mid-Study Randomization: Ensuring Data Integrity In Oncology Trials7/5/2026
Miscommunication between supply chain vendors risks costly delays. Discover how unifying physical and digital operations catches issues before they disrupt a trial.
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Advancing Dose Escalation Strategies With Bayesian Modeling8/12/2025
A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.
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Delivering A Registrational GI Trial Through Ongoing Protocol Shifts10/17/2025
A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.
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How We Used Intelligent Automation to Transform Vendor Selection7/2/2025
Discover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.
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Duchenne Muscular Dystrophy Trial In China9/17/2025
A global sponsor conducting a Duchenne Muscular Dystrophy trial in China required reliable patient travel solutions to support children and families.
NEWSLETTER ARCHIVE
- 07.06.26 -- The Patient Recruitment Debate Nobody's Having
- 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
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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![kaniel_cassady_01_edit_stairs]( "How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients")
Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
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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.
FOCUS ON PATIENTS
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![kaniel_cassady_01_edit_stairs]( "How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients")
Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
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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.
