When three drugs become one — the polypharmacology strategy, 505(b)(2) pathway, and objective endpoints Nuero-Innovators is relying on to bring new hope to stroke patients.
- 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?
- What Will Life Science Orgs Do When The AI Bill Comes Through?
- Clinical Trial Standards — What They Are And Why They're Indispensable
GUEST COLUMNISTS
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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.
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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.
CLINICAL TRIAL WHITE PAPERS
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![Organs-body-organoid-study-GettyImages-1157550305]( "Antibody-Drug Conjugates: 'Magic Bullets' Become Reality")
Antibody-Drug Conjugates: 'Magic Bullets' Become RealityCancer therapy has evolved from potent chemotherapy to targeted biological therapy, including antibody-drug conjugates (ADCs). Learn more about ADCs’ makeup, mechanisms, and the development landscape.
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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).
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Global e-Consent Matrix3/9/2026
Navigate complex regional regulations and identity requirements to modernize your global clinical trial enrollment. Ensure compliance and access while moving toward digital participant engagement.
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Disclosure Management System: Build Or Buy?6/19/2025
Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
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Decentralized And Community-Based Solutions Driving Women's Healthcare9/24/2025
Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
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Designing More Representative Trials Through Strategic Planning5/28/2025
Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How Pfizer Used Wearable DHTs To Reveal Meaningful Treatment Effects In Cancer Cachexia11/20/2024
Wearable digital health technologies (DHTs) played a crucial role in assessing patient-centric outcomes during pfizer's study into the benefits of using ponsegromab for treating cancer cachexia.
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CRO Uses CRIO eSource To Double Monitoring Productivity1/31/2025
Examine the transformative impact of eSource technology on monitoring productivity during a global Phase 3 trial conducted by a Contract Research Organization (CRO) amid the COVID-19 pandemic.
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Optimizing EDC Strategy And Data Collection for a Rare Disease Trial6/11/2025
Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.
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Maintain Compliance Through Divestiture Without Disrupting Operations6/25/2026
Facing a divestiture? Learn how to protect historical quality records and stay audit-ready throughout the transition.
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Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments1/29/2025
During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.
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How A Leading Chinese Biopharmaceutical Company Modernized Clinical Operations7/15/2026
A growing biopharma pipeline needed better document oversight. Learn how automation and centralized tracking improved compliance and trial visibility.
NEWSLETTER ARCHIVE
- 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
- 09.15.26 -- Build Explanation Layers For Different Stakeholders
- 09.14.26 -- Smarter Recruitment, Stronger Trials: Rare Disease Strategies, Ethical Ads & DCT Solutions
- 09.12.26 -- Beyond Reviewing Data: RBQM And EDC Integration
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.
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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.
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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?
