Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
- Social Media Is Replete With Patient RWD, But How Can Researchers Best Use It?
- How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis Suppurativa
- Unicycive Therapeutics' Framework For Speedier Clinical Trials
- Helus Shares Experience Studying Adjunctive Psychedelic For Major Depressive Disorder
- Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials
- RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short
- AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them
GUEST COLUMNISTS
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RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short
Chiesi's Rachele Berria, MD, Ph.D., discusses how RWE is reshaping rare disease drug development strategies, from leveraging registries and patient-reported outcomes to navigating evolving regulatory expectations.
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AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them
AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
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Will AI And Agile Project Management Help Advance RBM?
Will AI-based tools embedded into risk based-monitoring prompt an Agile project management moment for clinical research? Sidharth Ananthanarayan explains why AI-based tools are not the answer but part of it.
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The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future
The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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Why Building Long-Term Value And Making Clinical Progress Are Inextricable
Dicot Pharma CEO Elin Trampe discusses how clinical milestones, financing strategy, shareholder value, and partnering considerations must be tightly integrated in early development through late-stage planning.
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What Sponsors Don't See: The Systems Behind Clinical Trial Delivery
What do sponsors need from sites? Easy. How do they evaluate them? Not so easy (or accurate). In this column, Association Multisite Research Corporations (AMRC) Executive Director Jim Kremidas explains how sites and sponsors can make site evaluations better.
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What Really Happens At The Site When Sponsors Pull Back Mid-Trial
When sponsors slow or reduce operational spending due to financial pressure, strategic pivots, or internal restructuring, sites — and patients — suffer. Curo Research CCO Amy Bland explains how sponsors can better manage operational changes.
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A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI
Clinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.
CLINICAL TRIAL WHITE PAPERS
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Demanding More From AI Governance In Drug Safety
Embedding AI governance into your an AI-enabled 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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Powering More Efficient Clinical Development With AI And ML7/7/2025
Explore how AI and ML are revolutionizing clinical trials by automating data processes to accelerate research and transform data into actionable outcomes for patient care.
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A Promising Rebound in Clinical Trials10/23/2024
This report explores how clinical trials bounced back in 2023 from their decline a year earlier despite continued geopolitical, regulatory, and pricing pressures.
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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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The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality11/18/2024
Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.
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Combination Therapy Dose Optimization In Oncology Trials3/30/2026
Optimize dose selection in oncology trials by moving beyond toxicity limits. Use advanced modeling and benefit-risk analysis to improve efficacy and meet modern regulatory standards.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Sol-Gel Builds Awareness Of Rare Skin Condition, Generates Leads4/1/2026
Explore a 60-day HCP Awareness email campaign that surpassed industry benchmarks and generated a substantial number of leads.
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Quantitative ROI With DCTs11/13/2025
Through dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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Flexible Data Management For Growing Portfolio7/31/2025
Explore strategic enhancements to a small biopharma's biometrics capabilities involving the deployment of 20 specialized professionals, which effectively bolstered the client’s organizational capacity.
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Participant Support In Oncology Trials With Cachexia-Related Burden4/21/2026
Coordinated travel, reimbursements, and visit logistics for oncology participants experiencing fatigue, weight loss, and reduced mobility, helping reduce dropouts and keep people engaged.
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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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Recruiting & Retaining More Patients Per Site:3/14/2025
Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
NEWSLETTER ARCHIVE
- 07.06.26 -- The Patient Recruitment Debate Nobody's Having
- 07.03.26 -- Optimize Your Trial Data Journey
- 07.03.26 -- Maximizing Pipeline Value: From Portfolio Optimization To Early-Phase Efficiency
- 07.02.26 -- What Happens When Sponsors Pull Back Mid-Trial?
- 07.01.26 -- Bridging Community And Central Hospitals With Japan's DCT Model
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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Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
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AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
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Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
FOCUS ON PATIENTS
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Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.
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The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.