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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![Regulatory network digital EHR EMR patient data GettyImages-1298626492]( "Disclosure Management System: Build Or Buy?")
Disclosure Management System: Build Or Buy?Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
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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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Everest Group Life Sciences eCOA Peak Matrix Assessment 20259/16/2025
Discover how digital platforms are revolutionizing clinical trials by improving data quality and patient engagement in this comprehensive market assessment.
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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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Modernizing Clinical Trial Logistics To Deliver Value2/3/2026
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
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Digital Endpoint Resource Guide: Obesity And Related Metabolic Disorders8/15/2024
Explore how digital health technologies can enhance obesity treatment by providing critical insights beyond weight loss.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Advancing Neuromuscular Research with Digital Endpoints1/20/2026
Explore cutting-edge digital measures that capture peak mobility and activity in real-world settings, offering meaningful insights into disease progression in neuromuscular disorders.
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Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays9/25/2025
Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
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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.
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Drive Superior Enrollment, Speed, And Quality Using eSource1/3/2025
Explore a detailed analysis of 140 research sites involved in a Phase III trial, highlighting significant advancements in trial performance and data quality using CRIO’s eSource platform.
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Metabolic Disorders Clinical Trial Case Study9/17/2024
Check out this case study to learn how partnering with an accomplished contract research organization is essential in the complex and dynamic field of metabolic drug development.
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How Sponsors Can Leverage New Technologies To Lower Trial Costs1/6/2025
This study introduces sponsors to an innovative, lean, and efficient approach to data management that integrates site-facing technologies to streamline trial operations.
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.
