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.
- 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
- Judgement-Based Project Management Builds Partners' Trust
- 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
GUEST COLUMNISTS
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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.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1363170016 wearables]( "Wearables For Optical Cardiovascular Monitoring")
Wearables For Optical Cardiovascular MonitoringWearable 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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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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AI-Driven Signal Management: The Future Of Drug Safety12/19/2025
By combining autonomy with robust governance, agentic AI enables pharmacovigilance teams to move from reactive to proactive safety management, anticipating risks before they materialize.
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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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Practical Strategies For Diverse Trial Recruitment11/11/2024
The clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
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Eliminate Clinical Trial White Space With The Right AI Strategy10/9/2025
Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Accelerating Early Phase Oncology Study Development4/17/2025
Explore a close collaboration to co-develop a comprehensive, adaptive protocol designed to support key decisions across multiple trial phases for an innovative cancer therapy.
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Expand Bandwidth With A Trusted Regulatory Writing Partner9/18/2025
Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.
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Community Engagement vs. Digital Engagement For Higher Enrollment8/28/2024
Explore the importance of tailoring recruitment strategies to specific populations and leveraging diverse channels to reach potential participants.
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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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Changing The Clinical Feasibility Game With AI1/22/2026
AI is only as good as the data it’s built upon. Our customized AI platforms are constructed on a foundation of trustworthy, carefully curated data to produce detailed, expert-driven responses.
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How We Used Intelligent Automation to Transform Vendor Selection7/2/2025
Discover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.
NEWSLETTER ARCHIVE
- 05.27.26 -- STREAM Edition: Think Big, Start Small With AI
- 05.26.26 -- Human-In-The-Loop In AI Validation And Control
- 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
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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![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?"
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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.
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.
