For the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.
- Taking On Patient Recruitment From Another Angle — The Payer
- Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation
- My View: The Clinical Trials Technology Congress
- FDA's HALO Platform And Elsa 4.0: Five Critical Risks For Sponsors
- Biotech Ecosystem Helps Advance A New Approach To Inflammation Into Trials
- Synaptic Regeneration And The Future Of Alzheimer's R&D
- FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control
GUEST COLUMNISTS
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![Glowing digital neural network-GettyImages-2233500411]( "Synaptic Regeneration And The Future Of Alzheimer's R&D")
Synaptic Regeneration And The Future Of Alzheimer's R&DFor 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.
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![Angry businessman discussing with colleague-GettyImages-1133463611]( "FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control")
FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating ControlADRES Bio's Rivka Zaibel walks sponsors through the proper response to an FDA Form 483, emphasizing the need to show understanding and control of the situation.
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![Web negotiations, working remotely-GettyImages-1308313327]( "Judgement-Based Project Management Builds Partners' Trust")
Judgement-Based Project Management Builds Partners' TrustProject managers often operate under rules that govern how and when they execute tasks. But that doesn't always include room for individual judgment. But judgement, argues Jason Bork, is the differentiator in successful partnerships.
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![CTD story - GettyImages-1253880092 and Canva]( "How Did You End Up In Clinical Research?")
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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![Collaboration, growth in business-GettyImages-2216095959]( "From CRO Management To Networked Governance: The New Quality Imperative")
From CRO Management To Networked Governance: The New Quality ImperativeThe clinical research industry once emphasized transactional vendor management, but now it requires broader governance to enable the level of quality that enables scalability and success.
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![Focus on FDA-GettyImages-2229675668]( "Will FDA's One-Day Inspection Pilot Stand The Test Of Time?")
Will FDA's One-Day Inspection Pilot Stand The Test Of Time?FDA's complementary pilot could help weed through a persistent examination backlog, but uncertainty and upheaval in leadership at the top puts its future in question.
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![risk-GettyImages-1419222683]( "QA Transitions Don't Create Inspection Risk — They Reveal It")
QA Transitions Don't Create Inspection Risk — They Reveal ItConsultant Wijdan Suliman, MD, MHA, explains how QA leadership changes can reveal risks, including differences in the interpretation, lost historical context, and more.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1417217605_Australia]( "Streamlining Clinical Trial Start-Up In Australia")
Streamlining Clinical Trial Start-Up In AustraliaGain a comprehensive overview of how sponsors can accelerate clinical trial start-up in Australia, leveraging the nation’s unique strengths as a global hub for clinical research.
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Automated Evidence Generation For Regulatory-Grade RWD10/20/2025
Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.
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Breaking Through Barriers With Integrated Trial Optimization5/9/2025
In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.
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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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Clinical Trial Starts Rose At Slower Pace In 202412/8/2025
Clinical trial starts grew 5.5% to 10,503 in 2024, a slowdown from 2023’s 9.4% rise in trial starts. Sustained geopolitical and global regulatory pressures on pharma contributed to curbing momentum.
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Overcoming Challenges In Obesity Trials2/12/2026
Obesity trials face high dropout rates due to long durations and complex requirements. Overcome these hurdles with personalized engagement, expert lifestyle support, and proactive patient care.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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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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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Drilling Down On Diversity And Feasibility12/8/2025
A mid-sized contract research organization (CRO) sought help with writing clinical trial diversity action plans and assessing feasibility for therapeutic areas outside its usual scope.
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AI In Clinical Data Management: How Does It Work?8/18/2024
AI is revolutionizing clinical data management by automating medical coding, data reconciliation, and audit trail reviews, significantly enhancing efficiency and accuracy.
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
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Electronic Body Maps Drive Standardization Across Top-10 Pharma7/8/2024
Learn how a top-10 pharmaceutical client was able to "fundamentally transform the way they execute clinical trials" with the digitization and standardization of pain maps in a diabetic polyneuropathy trial.
NEWSLETTER ARCHIVE
- 05.29.26 -- Improve Your Patient Recruitment Success
- 05.28.26 -- From CRO Management To Networked Governance
- 05.28.26 -- Prepare For 2026 With Systems That Scale With Every Stage Of Growth
- 05.27.26 -- Why Clinical And Commercial Development Must Be Integrated Fully And Early
- 05.27.26 -- STREAM Edition: Think Big, Start Small With 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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![Healthcare benefits enroll-GettyImages-882379348]( "Taking On Patient Recruitment From Another Angle — The Payer")
Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
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![IRB ad approval-Getty image 1075404882]( "Clinical Trial Ads, Informed Consent, And Half-Hearted Regulation")
Should informed consent really start with clinical trials ads? And if not, why do IRBs need to be involved in their approval? Paul Ivisin unravels the tangled web of IRBs, regulators, and clinical trial advertisements.
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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?"
FOCUS ON PATIENTS
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![GLP-1 agonist injector pen, medical measuring tape-GettyImages-2226642622]( "Why Tolerability Will Drive The Next Wave Of Obesity Treatments")
For the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.
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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.
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![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.
