Clinical trial standards are essential. But to interpret changes, preserve meaning, and assess downstream impact, context is key.
- 5 Ways To Enrich The Clinical Trial Ecosystem
- The Promise Of MRD-Guided CAR-T Treatment
- Your Trial Shows Up In AI. Now What?
- Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology Trials
- How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure
- The SIP Problem Is Bigger Than SIP
- Lessons In Forecasting Discipline From A $40B Supply Chain
GUEST COLUMNISTS
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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.
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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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Planning A Global Clinical Trial With The Right Sites, Not The Most Sites
Less is more for Yi Larson and the team at Excursion Therapeutics, which opted to build right site network — not the largest one — for its Phase 2 trial.
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Turning Pediatric Cancer Discoveries Into Medicines Requires Better Connections
Promising pediatric cancer science often stalls before patients benefit. David Adler explains how better connections could change that.
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Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
How can sponsors revive a promising modality with known safety limits? Vast Therapeutics CEO Nate Stasko, Ph.D., explains how ALX1 is reshaping nitric oxide delivery.
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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?
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Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy
Can priming with oncolytic viruses be a better path to reeducating the immune system to recognize and attack cancer? Oncolytics Biotech advisor Richard Vile, Ph.D., says yes.
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4 Ways That AI And Point-Of-Care Diagnostics Are Redefining Clinical Trial Design And Operations
Discover how AI-enhanced point-of-care diagnostics are changing trial design and what ClinOps should do next.
CLINICAL TRIAL WHITE PAPERS
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Modernizing Clinical Trial Oversight: The Path To Clinical Operations Excellence
Examine the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.
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Practical Strategies For Diverse Trial Recruitment11/11/2024
The clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
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Matching Pharmacovigilance Methodology To Organizational Scale8/12/2026
One-size-fits-all doesn't work for safety signal detection. Discover a scalable framework that keeps expert judgment at the center — no matter how large your portfolio grows.
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How Sponsors Can Drive Success With Central eSource At Investigator Sites6/17/2025
Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.
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If Data Integrity Matters, Paper Is Not An Option3/5/2026
Ditch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.
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Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How Expert Medical Information Support Strengthened A Rare Respiratory Therapy Launch5/26/2026
Embedded medical information expertise enabled compliant, real‑time scientific engagement with healthcare professionals at a high‑profile congress during a critical product launch.
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Navigating Choppy Waters: Rapid Study Completion For An Anti-Nausea Compound7/17/2026
See how strategic technology reuse and real-time query resolution allow study teams to successfully manage high-volume, rapid participant enrollment without compromising data quality.
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Post-Market Safety And Risk Management in DMD4/11/2025
The pharmaceutical company specializing in rare neurological diseases sought solutions after encountering significant hurdles in post-market safety surveillance.
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Drive Superior Enrollment, Speed, And Quality Using eSource1/3/2025
Explore a detailed analysis of 140 research sites involved in a Phase III trial, highlighting significant advancements in trial performance and data quality using CRIO’s eSource platform.
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Delivering Complex Oncology Trials At Scale5/19/2026
Parexel delivered two complex, global Phase III prostate cancer trials by aligning site selection, logistics, imaging workflows, and RAM regulatory expertise—achieving faster enrollment and on‑time execution.
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Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan2/7/2025
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
NEWSLETTER ARCHIVE
- 09.04.26 -- Data Accuracy Meets Patient Access: Innovations Driving Clinical Trials Forward
- 09.04.26 -- From Intelligent RTSM To Inspection Readiness: Smarter Clinical Workflows
- 09.03.26 -- Faster FDA Pathways, Smarter Partnerships: Rethinking How Trials Get Done
- 09.03.26 -- Finding The Right Trial Model For Better Study Outcomes
- 09.02.26 -- Can Digital Endpoints Really Accelerate 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?