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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![AI contract 1 (2)]( "Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3)")
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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![AI contract 1]( "Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2)")
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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![AI contract-GettyImages-2207503201]( "Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)")
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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![Mother abd adult daughter at doctors-GettyImages-2213748134]( "Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study")
Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS StudyBeing 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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![build trust-GettyImages-1175873327]( "It's A Fact: Sharing Clinical Trial Results With Participants Builds Trust")
It's A Fact: Sharing Clinical Trial Results With Participants Builds TrustCISCRP 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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![Find clinical trials for-GettyImages-1418948426]( "When AI Agents Start Researching Trials On Behalf Of Patients, What Happens?")
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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![Lab Experiment-GettyImages-157697835]( "The U.S. Clinical Trial Recruiting Pipeline Report – May 2026")
The U.S. Clinical Trial Recruiting Pipeline Report – May 2026This 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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![scale AI-GettyImages-804989330]( "Safe And Scalable AI Deployment For Clinical Trials")
Safe And Scalable AI Deployment For Clinical TrialsWhen 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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![GettyImages-1316574146-computer-monitoring-office-hands-keyboard]( "The Next Era Of eCOA Is AI")
The Next Era Of eCOA Is AIDiscover how AI is moving beyond the hype to streamline clinical study builds. Explore practical ways to automate protocol digitization and UAT scripts while preparing for future patient tools.
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Innovating With Generative And Agentic Artificial Intelligence3/30/2026
Discover how specialized AI is revolutionizing clinical trials by enhancing data quality and operational speed through curated training, human oversight, and objective scientific analysis.
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Cell And Gene Therapy Field Quiet In Q28/15/2024
While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
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Wearables For Optical Cardiovascular Monitoring6/10/2025
Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).
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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.
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Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape9/1/2025
Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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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Recruitment To Screening: Bridging The Gap12/5/2025
Explore how providing tracked transportation for patients can streamline recruitment, improve site conversion rates, and deliver measurable ROI for clinical trials.
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Market Approval For A Novel Non-Hodgkin Lymphoma (NHL) Therapy4/11/2025
Explore a collaboration that underscores the importance of strategic planning and regulatory engagement in the approval process.
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Tailored Approach Supports Bladder Cancer Breakthrough3/5/2026
Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.
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Rescuing Data Integrity: A Swift Transition And Quality Transformation11/14/2025
Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.
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Sleep Assessment In Sleep Disorders3/16/2026
Discover how continuous, objective monitoring in a home environment captures sleep improvements that traditional lab-based snapshots often miss, ensuring more accurate clinical outcomes.
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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![CTD story - GettyImages-1253880092 and Canva]( "How Did You End Up In Clinical Research?")
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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![Find clinical trials for-GettyImages-1418948426]( "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.
-
![Lab Experiment-GettyImages-157697835]( "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.
FOCUS ON PATIENTS
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![Mother abd adult daughter at doctors-GettyImages-2213748134]( "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.
-
![build trust-GettyImages-1175873327]( "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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![prescription instructions-GettyImages-1785706494]( "Precision Medicine Needs Better Infrastructure — And We Already Have The Models For It")
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.
