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-1463515619 home visit nurse]( "The True ROI Of Decentralized Clinical Trials")
The True ROI Of Decentralized Clinical TrialsGain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
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Pharma R&D Annual Review Supplement: New Active Substances4/15/2026
Last year was by some distance the best year ever in terms of new active substances. Its total of 105 new debuts easily outstrips that of the previous record holder 2021’s 97. In 2025 we saw 97 new drugs, compared to the previous record of 84.
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Why Life Science Organizations Need A Chief Patient Officer Function4/27/2026
Bridging the gap between innovation and impact, this exploration of the Chief Patient Officer role offers a strategic framework to integrate patient insights and de-risk the product lifecycle.
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The Next Era Of eCOA Is AI4/15/2026
Discover how AI is moving beyond the hype to streamline clinical study builds. Explore practical ways to automate protocol digitization and UAT scripts while preparing for future patient tools.
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The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality11/18/2024
Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.
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Offline eCOA: The Real-Time Monitoring Dilemma3/9/2026
Balance the need for offline data safety with the necessity of real-time monitoring. Learn how to navigate new regulatory requirements for source devices while maintaining high patient compliance.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Enhancing Investigator Training And Communication During COVID-196/26/2024
Centralizing all trial-related information, enabling seamless interaction and global team coordination through Scout Academy.
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Launching A Unified Global Sales Team In 90 Days11/7/2025
A global CRO united 300+ sales and executive leaders across five continents for a dynamic, space-themed meeting that strengthened culture, deepened product understanding, and inspired alignment toward annual growth goals.
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Increasing Efficiency And Reducing Drug Waste10/2/2025
Discover how streamlined clinical supply chain management helped accelerate study timelines, reduce costs, and support global treatment delivery through a strategic technology partnership.
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Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
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Improving Clinical Trial Performance Through Central eSource10/23/2025
See how a top five pharmaceutical company leveraged our esource platform to enhance site performance, improve data consistency, and enable remote monitoring.
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Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice10/30/2024
See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.
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.
