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
-
![diversity - equality iStock-1303294233]( "Practical Strategies For Diverse Trial Recruitment")
Practical Strategies For Diverse Trial RecruitmentThe clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
-
Strategies For Post-Approval Lifecycle Management And Local PV7/12/2024
If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.
-
Patient-Focused Data Capture For Cancer Research8/21/2025
In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.
-
2026 State Of Clinical Trial Technology: The Five Strategic Imperatives3/12/2026
AI acceleration and digital fragmentation are reshaping clinical trials. Discover five imperatives driving interoperability, smarter site enablement, and data‑ready workflows for future‑ready operations.
-
Powering More Efficient Clinical Development With AI And ML7/7/2025
Explore how AI and ML are revolutionizing clinical trials by automating data processes to accelerate research and transform data into actionable outcomes for patient care.
-
State Of Clinical Trial Technology: The AI Inflection Point2/12/2026
Digital maturity gaps are widening in clinical research. Connected workflows speed insights and execution, while manual processes leave organizations increasingly behind.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Expanding Clinical Research In East Africa With Digital Innovation12/11/2025
Africa carries 25% of the world’s disease burden but hosts only 1% of clinical trials. Discover technology-driven strategies that close this gap and transform research access in underserved regions.
-
Helping To Power The WHO Solidarity Trial Against COVID-193/21/2025
To overcome the unprecedented challenges of large-scale global clinical trials, adopting data capture solutions is essential for ensuring the success of critical research initiatives.
-
How To Unlock The Secret To Repeatable, Scalable Low Turnover6/7/2024
Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.
-
Data Key In Addressing Patient Recruitment Challenges6/19/2025
Explore how a Phase II trial for extensive-stage and previously treated small cell lung cancer overcame recruitment challenges with a data-driven solution designed to surface protocol-matched patients.
-
Phase 1 Trial In Painful Diabetic Peripheral Neuropathy2/24/2026
A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.
-
The Perfect Solution For Recruitment, Retention, And ROI8/15/2024
See how Citeline Connect was deployed to advance enrollment six months ahead of schedule for a sponsor’s Phase IV atopic dermatitis trial and build a community of engaged patients.
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.
-
![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.
