For too long, treating Alzheimer’s disease has been a case of “managed decline.” We need to move beyond slowing disease progression toward achieving tangible functional recovery.
- Can Independent Pharmacies Succeed Where Walgreens Failed?
- How Did You End Up In Clinical Research?
- From CRO Management To Networked Governance: The New Quality Imperative
- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
- QA Transitions Don't Create Inspection Risk — They Reveal It
- Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3)
- Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2)
GUEST COLUMNISTS
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Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3)
Leibowitz Law shares the third installment of its three-part series on contracting for AI in clinical trial operations. Part 3 picks up with cybersecurity, monitoring and validation, and risk allocation.
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Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2)
Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 2 demonstrates why organizations must understand where it is used, how it interacts with data, and where the risks lie.
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Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)
Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 1 outlines where AI appears in ClinOps and supporting technologies, and the questions companies and organizations should ask when AI touches data.
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Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study
Being time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.
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It's A Fact: Sharing Clinical Trial Results With Participants Builds Trust
CISCRP experts share results from their annual Perceptions & Insights Study showing that patients continue to place a high value on receiving both individual and overall study results.
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When AI Agents Start Researching Trials On Behalf Of Patients, What Happens?
Right now, patients are using AI agents to find clinical trials. But soon enough, these AI tools will be doing it on their own and feeding patients the results. Recruitment expert Ross Jackson discusses this shift and what it will mean for sponsors.
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The U.S. Clinical Trial Recruiting Pipeline Report – May 2026
This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from March 7 to May 1, 2026.
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Safe And Scalable AI Deployment For Clinical Trials
When life sciences organizations lack a structured, evidence-based methodology for scaling AI tools safely and effectively, they put clinical development at risk. Partha Anbil and Partha Khot team up to share a practical approach to its implementation.
CLINICAL TRIAL WHITE PAPERS
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Challenges And New Approaches To Developing Clinical Evidence For Medical Devices
Learn about the challenges and new approaches to developing clinical evidence for medical devices, including decentralized trials, adaptive studies, in silico trials, and real-world evidence.
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Optimizing Site Activation To Accelerate Clinical Trials6/5/2025
Clinical trial site activation delays are a major bottleneck in drug development, hampering trial timelines and funding flows. To reverse this trend, site-focused solutions are being prioritized.
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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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Unique IRT Implementation Considerations For Personalized Medicine Trials8/22/2025
The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.
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Challenges, Opportunities For Recruitment In The Digital Age10/20/2025
Health literacy gaps and online misinformation hinder clinical trial recruitment. Meeting patients where they are — digitally and educationally — can improve engagement and enrollment success.
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What the FDA Looks For In Global Development Programs Today1/16/2026
Mastering the complexities of multi-regional clinical trials requires aligning global data with evolving regulatory expectations to ensure treatment consistency and successful drug approval.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Enhance Access And Improve Retention In Rare Disease Trials With HTS4/17/2025
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
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Building A High-Quality IND From Scratch With Strategic Gap Analysis8/12/2025
A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).
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Transforming Clinical Trial Sites With Research Study Rockstar2/10/2025
This innovative platform streamlines workflows, automates patient communication, and provides intuitive dashboards to address prevalent pain points faced by trial coordinators.
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Use Case: A Patient-Centric Approach To Site Selection1/27/2025
Discover how Citeline’s robust datasets, combined with real-world data, inform intelligent site and investigator selection for a rare, autoimmune disease.
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How Cara Therapeutics Increased Compliance And Reduced Study Team Burden7/31/2025
Delve into the partnership that helped Cara Therapeutics achieve a significant milestone in their clinical research efforts to transform the lives of chronic pruritus patients.
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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.
NEWSLETTER ARCHIVE
- 05.22.26 -- Reimagine Data Governance For The AI Era
- 05.22.26 -- CROs Helping Emerging Biotechs And Drug Developers
- 05.21.26 -- The U.S. Clinical Trial Recruiting Pipeline Report – May 2026
- 05.20.26 -- The Legal Consequences Of AI In Clinical Research
- 05.20.26 -- STREAM Edition: Regulatory Compliance And Trusted AI
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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To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"
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Right now, patients are using AI agents to find clinical trials. But soon enough, these AI tools will be doing it on their own and feeding patients the results. Recruitment expert Ross Jackson discusses this shift and what it will mean for sponsors.
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This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from March 7 to May 1, 2026.
FOCUS ON PATIENTS
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Being time conscious and attuned to patient needs are two contributing factors to trials that recruit and retain patients for the duration.
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CISCRP experts share results from their annual Perceptions & Insights Study showing that patients continue to place a high value on receiving both individual and overall study results.
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Standard methods for evaluating clinical trial representativeness perform poorly when the trial population differs from the broader disease population in a patient registry. June Cha, Ph.D., MPH, explains how the right metrics can make a difference.