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
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
-
![GettyImages-1090255620-lab-research-microscope-computer]( "Innovating With Generative And Agentic Artificial Intelligence")
Innovating With Generative And Agentic Artificial IntelligenceDiscover how specialized AI is revolutionizing clinical trials by enhancing data quality and operational speed through curated training, human oversight, and objective scientific analysis.
-
Unlock The Power Of Clinical Data Science3/9/2026
Discover a unified, AI‑driven approach that helps clinical teams manage growing data complexity, accelerate insight generation, and improve trial oversight to enable faster decisions.
-
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.
-
Endpoint Clinical RTSM: Getting The Job Done12/5/2025
Explore how a Job-to-be-Done (JTBD)-focused RTSM approach reduces delays, optimizes costs, and accelerates trial success through predictive intelligence and streamlined global workflows.
-
Rewriting The Future Of Clinical Trials8/8/2025
In an increasingly data-complex environment, eCOA is emerging as a foundational pillar for both operational agility and scientific rigor in clinical development
-
A Guide to Digital Endpoints in Respiratory Diseases4/15/2025
Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Biotech Delivers A Superior Patient And Site Experience3/4/2025
To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.
-
Increasing Participation In World-Class Cancer Research In Northwest Arkansas3/26/2026
Discover how data automation and integrated screening help community cancer centers offer clinical research as a standard care option, ensuring all patients have access to the latest treatments.
-
Outgrowing Excel: Implementing RTSM In A Live Phase I Trial2/25/2026
Learn how a clinical-stage oncology biotech successfully transitioned a live Phase I trial from manual spreadsheets to RTSM without disrupting site momentum or patient enrollment.
-
Duchenne Muscular Dystrophy Trial In China9/17/2025
A global sponsor conducting a Duchenne Muscular Dystrophy trial in China required reliable patient travel solutions to support children and families.
-
Overcoming Unexpected Obstacles In A Phase 1 Study1/29/2025
Discover how the implementation of mobile vision clinics (MVCs) was used to enhance efficiency in a Phase 1 clinical trial.
-
Breaking Free From Process Paralysis In Clinical Trials1/13/2025
Explore the implementation of CRIO’s eSource solution by a leading pharmaceutical company to overcome process paralysis in clinical research.
NEWSLETTER ARCHIVE
- 05.18.26 -- Reinterpreting Belmont For Contemporary Clinical Trials
- 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
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.
-
![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.
-
![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
-
![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.
-
![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.
