A new Charcot-Marie-Tooth guidance introduces practical recommendations to help sponsors design clearer, more patient-centered, regulator-ready trials.
- 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
- Last-Mile Lessons For Depot-To-Site Delivery
- What SIP Gets Right And Where It Still Falls Short
GUEST COLUMNISTS
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Last-Mile Lessons For Depot-To-Site Delivery
Depot-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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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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5 Ways To Enrich The Clinical Trial Ecosystem
Sponsors 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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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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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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Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology Trials
Aprea’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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How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure
By 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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Lessons In Forecasting Discipline From A $40B Supply Chain
Forecasting 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.
CLINICAL TRIAL WHITE PAPERS
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The Complexities Of Effective Patient Retention In Clinical Trials
Identifying and enrolling the right-fit patients from the outset is essential, but so is implementing comprehensive retention strategies that prioritize patient comfort, trust, and ongoing engagement.
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Deriving Reliable Clinical Outcome Scores From Continuous DHT Data6/10/2025
DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.
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Developing Next-Generation Therapies For Breast Cancer Patients9/8/2026
Breast cancer trials span multiple subtypes and modalities. Learn how specialized oncology experience helps reduce enrollment risk and keep programs on track.
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How Adaptive Design Accelerates Early‑Phase NSCLC Development5/22/2026
Adaptive trial designs and an adaptive mindset enable non-small cell lung cancer (NSCLC) sponsors to optimize dose, respond to evolving expectations, and accelerate early‑phase development.
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Faster Starts, Stronger Finish: Operational Excellence In NSCLC5/22/2026
In NSCLC trials, data‑driven site selection, streamlined protocols, efficient screening strategies, and proactive engagement can accelerate enrollment and improve trial efficiency across regions.
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Rethinking Trial Access Through Trust-Driven Design And Local Collaboration5/19/2026
Locally embedded research models help sponsors reach underserved populations while reducing burden on patients and health systems alike.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Accelerating A Schizophrenia Trial While Ensuring Quality7/31/2026
Tight timelines and rising patient targets don't have to derail a trial. See how speed and data quality can work together from enrollment to database lock.
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Transforming Clinical Trial Management5/5/2026
See how Vestigo® can transform your study management — streamline workflows, strengthen compliance, and eliminate inefficiencies by adopting a smarter, digital-first approach today.
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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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Preparing The Next Generation Of Clinical Research Professionals9/4/2025
Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.
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Expand Bandwidth With A Trusted Regulatory Writing Partner9/18/2025
Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.
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Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays9/25/2025
Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
NEWSLETTER ARCHIVE
- 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
- 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
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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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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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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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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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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Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
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Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?