Discover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.
- 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
- How Can We Influence Others For Better Outcomes In Clinical Research?
GUEST COLUMNISTS
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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.
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![online question and answer, problem-solving, and digital communication-GettyImages-2241803274]( "Your Trial Shows Up In AI. Now What?")
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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1025834378-manufacturing-excipient-drug-pharma]( "Navigating Adverse Immunostimulation: A Practical Guide For Clinical Researchers")
Navigating Adverse Immunostimulation: A Practical Guide For Clinical ResearchersExplore a systematic approach to evaluate adverse immunostimulation (AIS) in drug development through standardized biomarker sampling and tailored management strategies.
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The EMR Interoperability Dream Vs. Clinical Research Reality10/20/2025
Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.
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The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials More3/25/2026
High-end technology cannot fix poor rater preparation or complex patient needs. True data integrity requires bridging the gap between digital platforms and the reality of clinical implementation.
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Cross-Functional Best Practices For Signal Detection In Special Case Scenarios9/7/2026
When trial data fall short, real risk signals surface in inquiries, complaints, and reports. Learn how coordinated, cross-functional practices help catch risk earlier.
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Navigating The European Market's Regulatory Complexities12/30/2024
Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.
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10 Clinical Research Practices That Feel Like Compliance (But Aren't)3/24/2026
Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Expanding Access To Post-Market Safety Exams For Cystic Fibrosis Medication1/29/2025
This study highlights the transformative impact of point-of-need care on patient access, focusing on pediatric cystic fibrosis (CF) patients requiring essential eye exams.
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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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Transforming Ophthalmic Assessments For A Mid-Trial Protocol Change7/9/2026
Discover how a biopharmaceutical company integrated urgent mid-trial mandates across 65 sites, cutting standard onboarding timelines in half while preserving critical enrollment milestones.
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Overcoming Unexpected Obstacles In A Phase 1 Study1/29/2025
Discover how the implementation of mobile vision clinics (MVCs) was used to enhance efficiency in a Phase 1 clinical trial.
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Scaling Success: A Blueprint For Flexible Biometrics Partnerships2/19/2026
Learn how a micro-FSP model and integrated biometrics team can scale from specialized support to a full-service solution, ensuring agility and consistency as clinical trial needs evolve.
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Increasing Participation In World-Class Cancer Research In Northwest Arkansas3/26/2026
Discover how data automation and integrated screening help community cancer centers offer clinical research as a standard care option, ensuring all patients have access to the latest treatments.
NEWSLETTER ARCHIVE
- 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
- 09.16.26 -- From Sample Handling To Site Support: What's Powering Trial Success
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.
-
![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.
