AI can help study start-up teams move from tracking delays to predicting risks—if human judgment, data quality, and governance stay central.
- Why ING Feels Different
- How Can We Influence Others For Better Outcomes In Clinical Research?
- What Will Life Science Orgs Do When The AI Bill Comes Through?
- Clinical Trial Standards — What They Are And Why They're Indispensable
- Last-Mile Lessons For Depot-To-Site Delivery
- What SIP Gets Right And Where It Still Falls Short
- Turn AI Visibility Into Action: Build Explanation Layers For Different Stakeholders
GUEST COLUMNISTS
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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.
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![aprea-GettyImages 2151588975]( "Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology Trials")
Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology TrialsAprea’s Gene Kennedy explains how smart dose escalation, next-gen sequencing, and combination planning are helping the company advance its oncology trial for multiple solid tumor types.
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![MRI scanner-GettyImages-978265118]( "How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure")
How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial InfrastructureBy pairing donor priorities with research needs at Children's National, Milken Institute SPARC is turning philanthropy into faster trials, stronger infrastructure, and long-term care goals.
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![Warehouse task setup-GettyImages-2256605674]( "Lessons In Forecasting Discipline From A $40B Supply Chain")
Lessons In Forecasting Discipline From A $40B Supply ChainForecasting errors rarely start with the algorithm. They start when protocol changes, enrollment and site data reach the supply plan too late to prevent waste and disruption.
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![pharmacist, service, guidance, patient care-GettyImages-2260105068]( "The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option")
The Pharmacy Benefit No One Is Managing: Clinical Research As A Care OptionPharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
CLINICAL TRIAL WHITE PAPERS
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![eCOA-clinical-GettyImages-1331758896]( "The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials More")
The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials MoreHigh-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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Flexibility In Drug Development: From Tactical Response To Strategic Discipline8/10/2026
Historically managed through late-stage adjustments, operational adaptability has become a strategic imperative to prevent programs from stalling under real-world pressures.
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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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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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Futureproofing Post-Approval Compliance4/15/2026
In the post-approval stage, a synergistic operating model brings PV and regulatory functions under one umbrella: a single governance structure with shared decision cycles, templates, and evidence.
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Potential Of eClinical Solutions To The Complexity Of Oncology Trials7/31/2025
How are eClinical technologies—specifically IRT and eCOA— being leveraged to overcome patient recruitment difficulties, high mortality rates, and the intricacies of cancer treatments.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
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Improving Clinical Trial Performance Through Central eSource10/23/2025
See how a top five pharmaceutical company leveraged our esource platform to enhance site performance, improve data consistency, and enable remote monitoring.
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Sensors And On-Demand eCOA7/13/2026
See how one rare disease trial eased caregiver burden by unifying glucose monitoring and patient diaries into a single app with real-time safety alerts.
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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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Leading Recruitment With A Strong Alzheimer's Referral Pool2/24/2026
A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.
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Relieving Pressure During Preparation Of A High-Volume sNDA5/27/2026
Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.
NEWSLETTER ARCHIVE
- 09.14.26 -- Smarter Recruitment, Stronger Trials: Rare Disease Strategies, Ethical Ads & DCT Solutions
- 09.12.26 -- Beyond Reviewing Data: RBQM And EDC Integration
- 09.11.26 -- Better Data, Faster Trials: How AI And Standards Are Reshaping Clinical Research
- 09.10.26 -- The Vanishing Middle: How Consultants And CROs Are Reshaping Clinical Trials
- 09.10.26 -- Solving The Complexities of Rare Disease Clinical Development
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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![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.
-
![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.
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![neuroscience, biotechnology, organ printing, future medical innovation-GettyImages-2249745453]( "It Is Time To Require Human-Relevant Efficacy Evidence Before First-In-Human Trials")
Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?
