How can clinical research project management be optimize by AI? To determine its best fit, consultant Jason C. Bork assess AI's utility in project management through the lens of Plan, Do, Check, Act (PDCA).
- Before AI Can Transform Clinical Trials, It Needs More Patient Data
- CTTC Opens With A Reality Check On AI
- How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients
- 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
GUEST COLUMNISTS
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![armpit lymph pain-GettyImages-1671734100]( "How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis Suppurativa")
How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis SuppurativaElisa Maggioli, Ph.D., explains that improving outcomes in HS may depend on moving beyond broad, symptom-based approaches toward more targeted, biologically informed strategies.
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![Calendar-GettyImages-2237279814]( "Unicycive Therapeutics' Framework For Speedier Clinical Trials")
Unicycive Therapeutics' Framework For Speedier Clinical TrialsUnicycive Therapeutics Vice President of R&D Guru Reddy, Ph.D., shares how his small team moved swiftly through a recent early phase trial.
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![consoling-GettyImages-2190851878]( "Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive Disorder")
Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive DisorderHelus Pharma CMO Amir Inamdar discusses the strategic rationale behind its Phase 3 trial for major depressive disorder, including its adjunctive-treatment approach, patient population selection, and endpoint strategy.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-2179548801-ADC-3d-render]( "A New Era Of ADC Development Demands A New Kind Of Partner")
A New Era Of ADC Development Demands A New Kind Of PartnerExplore 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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What Re-Acquisition In Retinal Imaging Is Really Costing Your Program4/6/2026
High 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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Human-Centered RTSM Design Enhances Data, Safety, And Operations12/5/2025
Uncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
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What Is ICH GCP, And How Does It Impact Clinical Planning?10/20/2025
The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.
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Patient-Reported Outcome In Oncology Clinical Trials4/17/2025
As cancer therapies grow more complex and personalized, patient-reported outcomes (PROs) have emerged as a vital component of oncology research and care.
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Rewriting The Future Of Clinical Trials8/8/2025
In an increasingly data-complex environment, eCOA is emerging as a foundational pillar for both operational agility and scientific rigor in clinical development
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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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Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission1/27/2026
Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.
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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.
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Accelerating CRO Study Deployment At Scale7/7/2025
A top-3 CRO and a top-10 pharmaceutical company partnered with Medable to help accelerate, scale, and standardize their eCOA trials. See how they accomplished it.
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How To Seamlessly Integrate NetSuite With Power BI8/12/2024
Unlock the power of your NetSuite data with seamless integration to Power BI. Learn how to automate data refresh, gain real-time insights, and make informed business decisions.
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Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
NEWSLETTER ARCHIVE
- 07.09.26 -- Why "Steady Evolution" Best Describes AI's Future
- 07.09.26 -- Rewriting cancer… and patient recruitment
- 07.08.26 -- Accelerate Research: How AI, Master Protocols, And Better Recruitment Save Time
- 07.08.26 -- Why Australia Is A Strategic Launchpad For Early-Phase Studies
- 07.07.26 -- The Relationship Between AI And Clinical Trial Enrollment
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.
