Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
- It Is Time To Require Human-Relevant Efficacy Evidence Before First-In-Human Trials
- Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
- Building SIP Was The Hard Part
- Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy
- Accountability Gaps Can Break Clinical Supply Contracts
- 4 Ways That AI And Point-Of-Care Diagnostics Are Redefining Clinical Trial Design And Operations
- What BriaCell's Trial Design Says About Real-World Cancer Research
GUEST COLUMNISTS
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What BriaCell's Trial Design Says About Real-World Cancer Research
BriaCell President and CEO William Williams, MD, shares how broader eligibility criteria and physician’s choice controls can better reflect real-world cancer care.
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Accountability Gaps Can Break Clinical Supply Contracts
Contract gaps can create clinical supply failures when responsibilities differ across agreements. See how aligning obligations can prevent costly disputes, delays, and risks.
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'How Do You Feel?': Designing A Cardiac Trial With A Patient-Reported Primary Endpoint
Imbria Pharmaceuticals' Albert Kim, MD, Ph.D., shares why PROs are the point of the company's FORTITUDE-HCM trial for patients with non-obstructive hypertrophic cardiomyopathy.
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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.
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Building The Execution Architecture For Real-World Data To Have Real-World Impact
RWE's next challenge is execution. Learn how life sciences orgns can turn evidence into sustained business and clinical impact.
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Stock Options: Choosing The Right Viral Inoculum For An Early-Phase Norovirus Trial
Viral stock can make or break a norovirus challenge study. Cocrystal Pharma's Sam Lee explains why inoculum quality, infectivity, and availability matter.
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The Reality Of Clinical Research Federal Funding Cuts
Although the most catastrophic federal funding cuts didn't come to fruition, Pamela Garzone discusses where some impacts are being felt now and will be felt for years to come.
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Everyone Is A Consultant Now
Jon Newton argues clinical research’s “vanishing middle” is giving rise to a more flexible workforce of consultants, specialists, and boutique firms.
CLINICAL TRIAL WHITE PAPERS
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Modernizing Clinical Trial Logistics To Deliver Value
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
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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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A New, AI-Augmented Horizon For Safety And Pharmacovigilance1/6/2026
Is your organization leveraging AI to maximize efficiency in safety and regulatory workflows? If not, explore how these technologies are slated to improve industry approaches in 2026.
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A New Era Of ADC Development Demands A New Kind Of Partner3/30/2026
Explore how to navigate the evolution of antibody-drug conjugates by mastering AI-driven selection, dose optimization, and new regulatory strategies for earlier-line clinical success.
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The Impact Of High Inflation And The Great Resignation On Clinical Site Budgeting10/30/2024
The twin pressures of inflation and attrition prolong negotiations between sponsors and clinical sites, stalling drug development. Sponsors need up-to-date, reliable benchmark data to negotiate fair market value budgets.
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Phase 1 Clinical Trial Designs And Strategies9/18/2025
With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology5/2/2025
Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.
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Packaging And Labeling Support For A Global Cell Therapy Program8/10/2026
Master complex cell therapy logistics with coordinated depots, purpose-built labeling, and temperature-controlled solutions that protect product integrity.
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How Compassion Shaped This Pediatric Rare Disease Trial6/11/2025
Learn how kindness transformed the clinical trial experience for pediatric rare disease participants in a global study.
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Continuity And Risk Mitigation Following Unexpected QPPV Resignation5/26/2026
Rapid escalation and clear interim governance ensured compliance and operational continuity following an unexpected QPPV resignation, reducing inspection risk during a critical pharmacovigilance transition.
NEWSLETTER ARCHIVE
- 08.27.26 -- What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development
- 08.26.26 -- This WhichTrial Report Breaks Down The U.S. Clinical Trial Recruiting Pipeline
- 08.26.26 -- Explore AI-Driven Data Insights And Tools Reshaping Research
- 08.25.26 -- AI Risk, Patient Ethics And eClinical Tools: What's Driving Trials Forward
- 08.24.26 -- Bridge The Gap Between Raw Data And Clinical Enrollment
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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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.
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When designing and conducting trials for terminally ill patients, Kamila Novak reminds researchers to act and speak with respect, warmth, and thoughtfulness.
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Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.
FOCUS ON PATIENTS
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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?
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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.