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.
- Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study
- Why Site Engagement Isn't Just A Role Anymore
- It's A Fact: Sharing Clinical Trial Results With Participants Builds Trust
- When AI Agents Start Researching Trials On Behalf Of Patients, What Happens?
- The U.S. Clinical Trial Recruiting Pipeline Report – May 2026
- Safe And Scalable AI Deployment For Clinical Trials
- Collaboration Isn't Sexy. That's Kind of the Point.
GUEST COLUMNISTS
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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.
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![Financial technologies-GettyImages-1907659572]( "Small Biotech Survival: Navigating Risk And Capital Scarcity With AI")
Small Biotech Survival: Navigating Risk And Capital Scarcity With AIMaxine Opperman discusses the challenge and the necessity of small biotech's using AI, citing its pros, cons, and strategies for use.
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![risk, cybersecurity, hazard awareness-GettyImages-2272021966]( "5 Critical Risks With The FDA's Real-Time Trial Monitoring")
5 Critical Risks With The FDA's Real-Time Trial MonitoringLife science legal experts Kimberly Chew and Odette Hauke cover the FDA proof-of-concept real-time clinical trials (RTCTs) and expose five major issues that must be addressed before the pilot expands.
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![US president executive order-GettyImages-2264859508]( "Executive Order For Psychedelics")
Executive Order For PsychedelicsWe caught up with Joseph Tucker, Ph.D., CEO of Enveric Biosciences, to discuss the executive order for psychedelics.
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![US-EU-flag-3D-GettyImages-94920629]( "Aligning AI Use Clinical Trials With FDA And EMA Expectations")
Aligning AI Use Clinical Trials With FDA And EMA ExpectationsFor any trial conducted in the EU/EEA, regulators want to know that AI used across clinical trial planning, conduct, and analysis is transparent, controlled, and fit for purpose. Jessica Cordes explains how even U.S.-based teams must meet EMA expectations.
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![prescription instructions-GettyImages-1785706494]( "Precision Medicine Needs Better Infrastructure — And We Already Have The Models For It")
Precision Medicine Needs Better Infrastructure — And We Already Have The Models For ItStandard 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.
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![Fda Headquarters-GettyImages-2211199138]( "Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24")
Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.
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![tubes with blood samples, hematology test-GettyImages-1443027500]( "A Biomarker Playbook For Building Faster, Smarter Clinical Trials")
A Biomarker Playbook For Building Faster, Smarter Clinical TrialsNot every trial needs a biomarker, but every development leader should be assessing whether they can be effectively used to improve trial design, boost enrollment, reduce operational waste, and increase the likelihood that a study will answer the question it was built to answer.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1219551222-Patient-Person-Recruitment-Select]( "RWD, New Technologies Show Potential In Clinical Trial Recruitment")
RWD, New Technologies Show Potential In Clinical Trial RecruitmentLeveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.
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Demanding More From AI Governance In Drug Safety8/13/2025
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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Accelerate Drug Development With Master Protocols5/15/2025
Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
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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.
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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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Routes To Sponsor Of Choice: Shared Pipelines, Streamlined Payments10/30/2024
Paying clinical trial sites consistently on time provides stability and maintains positive relationships. Learn why being a sponsor of choice can mean the adoption of a singular clinical trial payments solution.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How Syneos Health Tackles Protocol Complexities1/7/2025
Explore solutions employed by Syneos Health, a global contract research organization, to optimize Phase I-IV clinical trials, particularly under a complex adaptive trial protocol.
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Medable Platform Delivers >90% eCOA Adherence And Scalability7/8/2024
Discover how eCOA use drove >90% adherence across an extensive weight management master protocol clinical trial with multiple sub-studies across 70+ research sites.
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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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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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Delivering Specialist Neurology Support4/17/2025
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
NEWSLETTER ARCHIVE
- 05.15.26 -- Clinical Trial Monitoring: Ensuring Compliance And Data Integrity
- 05.15.26 -- Protocol And Regulatory Support Services
- 05.14.26 -- Working (Well) With Patient Advocates: The Sponsor POV
- Reducing The Burden Of Patient Retention And Improving Continuity
- 05.13.26 -- STREAM Edition: Watch Presentations The Help You Grow And Improve Clinical Trials
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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![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.
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![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.
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![Senior woman with caregiver-GettyImages-2151920853]( "Static Reimbursement Structures Aren't Enough. Patients Need Whole-Person Support")
Fixed patient reimbursement isn't enough, says Donna Libretti Cooke, Erin Miller, and Jeanne M. Regnante. To truly care for patients and support their participation in a clinical trial, they need whole-person support.
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.
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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.
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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.
