John Yu, MD, of Kairos Pharma, explains why reversing treatment resistance could extend the life of proven cancer therapies and improve patient outcomes.
- Repurposing Three FDA-Approved Drugs For A New Stroke Recovery Strategy
- Before Adding AI, Fix The Process
- Coalition Takes Guesswork Out Of Charcot-Marie-Tooth Disease Research With New Guidance
- How AI Will Reshape Study Start-Up
- Clinical Supply Systems Need IT General Controls
- Medical Affairs: The Missing Link To Oncology Drug Adoption
- Why ING Feels Different
GUEST COLUMNISTS
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![metal chain-GettyImages-638503806]( "Medical Affairs: The Missing Link To Oncology Drug Adoption")
Medical Affairs: The Missing Link To Oncology Drug AdoptionLearn how medical affairs can help oncology teams turn strong clinical evidence into real-world adoption by connecting development strategy with clinical practice.
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![Teamwork, collaboration-GettyImages-2218614336]( "How Can We Influence Others For Better Outcomes In Clinical Research?")
How Can We Influence Others For Better Outcomes In Clinical Research?Learn how to use the Delphi method to build consensus and drive better decisions in clinical research — even when stakeholders start far apart.
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![AI making money-GettyImages-2271467935]( "What Will Life Science Orgs Do When The AI Bill Comes Through?")
What Will Life Science Orgs Do When The AI Bill Comes Through?AI is transforming clinical development, but what happens when usage costs spike? Jon Newton explains how to govern it before the bill lands.
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![Medical quality control-GettyImages-2072996733]( "Clinical Trial Standards — What They Are And Why They're Indispensable")
Clinical Trial Standards — What They Are And Why They're IndispensableClinical trial standards are essential. But to interpret changes, preserve meaning, and assess downstream impact, context is key.
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![warehouse worker checking barcodes-GettyImages-2265704054]( "Last-Mile Lessons For Depot-To-Site Delivery")
Last-Mile Lessons For Depot-To-Site DeliveryDepot-to-site delivery is more than a courier handoff. See how reconciliation gaps, temperature risks, and mismatched SLAs can turn last-mile issues into trial delays.
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![jackson AI part 2 using-GettyImages-2192428169]( "Turn AI Visibility Into Action: Build Explanation Layers For Different Stakeholders")
Turn AI Visibility Into Action: Build Explanation Layers For Different StakeholdersAI visibility isn’t just about being found. Ross Jackson coaches sponsors on how to influence AI to provide clear stakeholder pathways for clinical trial involvement.
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![Medical Hospital Surgery-GettyImages-2210492043]( "5 Ways To Enrich The Clinical Trial Ecosystem")
5 Ways To Enrich The Clinical Trial EcosystemSponsors must treat sites, PIs, and patients as connected parts of a living clinical trial ecosystem. Here are five ways to help make that happen.
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![Risk Assessment-GettyImages-2192813165]( "The Promise Of MRD-Guided CAR-T Treatment")
The Promise Of MRD-Guided CAR-T TreatmentMinimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.
CLINICAL TRIAL WHITE PAPERS
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![clinicla-trials-automation-GettyImages-2205446822]( "Strategic Implications Of The Single Phase 3 Approval Paradigm")
Strategic Implications Of The Single Phase 3 Approval ParadigmAs FDA single-trial approvals gain traction, CNS developers need stronger early evidence. Learn how biomarkers, patient selection, and regulatory strategy can accelerate development.
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Agentic AI And How It's Impacting Clinical Trial Research7/7/2025
Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
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The Renaissance Of Psychedelic Research: History, Protocols, And Forward Trajectories7/30/2026
Discover how clinical trial protocols are evolving to address unblinding, therapeutic support variables, and regulatory standards in modern psychedelic research.
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Demanding More From AI Governance In Drug Safety8/13/2025
Embedding AI governance into your safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.
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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.
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Wearables For Optical Cardiovascular Monitoring6/10/2025
Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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Taking Research In-House With CRIO: SciTech's Multi-Center Phase 1 Study1/6/2025
Explore the success story of an early-stage clinical pharmaceutical company that effectively navigated funding constraints when conducting its Phase 1 study without a third-party CRO.
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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.
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Migrating A Live Personalized Medicine Trial To Next-Gen RTSM3/26/2026
Discover how a clinical-stage biotech automated its supply chain to protect patient enrollment and eliminate manual errors in a complex, multi-national genetic medicine trial.
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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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Packaging And Labeling Support For A Global Cell Therapy Program8/10/2026
Master complex cell therapy logistics with coordinated depots, purpose-built labeling, and temperature-controlled solutions that protect product integrity.
NEWSLETTER ARCHIVE
- 09.21.26 -- The SIP Problem Is Bigger Than SIP
- 09.18.26 -- The Promise Of MRD-Guided CAR-T Treatment
- 09.18.26 -- Patients Are Dropping Out — Here's How Sites Are Closing The Gap
- 09.17.26 -- Five Ways To Enrich The Clinical Trial Ecosystem
- 09.16.26 -- Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy
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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![jackson AI part 2 using-GettyImages-2192428169]( "Turn AI Visibility Into Action: Build Explanation Layers For Different Stakeholders")
AI visibility isn’t just about being found. Ross Jackson coaches sponsors on how to influence AI to provide clear stakeholder pathways for clinical trial involvement.
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![online question and answer, problem-solving, and digital communication-GettyImages-2241803274]( "Your Trial Shows Up In AI. Now What?")
AI can explain your trial — but can it help patients act? Ross Jackson shares how sponsors can turn visibility into trust and next steps.
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![nurse and patient-GettyImages-1196843513]( "Sustainable Patient Engagement: Your Enrollment And Representation Depend On It")
Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.
FOCUS ON PATIENTS
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![business man looking through telescope-GettyImages-2215651052]( "Why Oncology Programs Can't Rely On An Inside View Alone")
Discover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.
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![Risk Assessment-GettyImages-2192813165]( "The Promise Of MRD-Guided CAR-T Treatment")
Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.
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![pharmacist, service, guidance, patient care-GettyImages-2260105068]( "The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option")
Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
