Project managers often operate under rules that govern how and when they execute tasks. But that doesn't always include room for individual judgment. But judgement, argues Jason Bork, is the differentiator in successful partnerships.
- From CRO Management To Networked Governance: The New Quality Imperative
- Will FDA's One-Day Inspection Pilot Stand The Test Of Time?
- QA Transitions Don't Create Inspection Risk — They Reveal It
- Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3)
- Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2)
- Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)
- Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS Study
GUEST COLUMNISTS
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![AI contract-GettyImages-2207503201]( "Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)")
Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1)Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 1 outlines where AI appears in ClinOps and supporting technologies, and the questions companies and organizations should ask when AI touches data.
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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")
Designing Trials Patients Can Actually Complete: Lessons From The SWIFT Deep TMS StudyBeing 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")
It's A Fact: Sharing Clinical Trial Results With Participants Builds TrustCISCRP 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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![Find clinical trials for-GettyImages-1418948426]( "When AI Agents Start Researching Trials On Behalf Of Patients, What Happens?")
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")
The U.S. Clinical Trial Recruiting Pipeline Report – May 2026This 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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![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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-949947192 lab, data]( "The EMR Interoperability Dream Vs. Clinical Research Reality")
The EMR Interoperability Dream Vs. Clinical Research RealitySeamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.
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A 2025 Survey Report Uncovers The Top 5 Clinical Trial Cost Insights4/22/2025
In this 2025 survey of over 100 U.S. clinical trial participants and caregivers, we reveal that most individuals join trials seeking life-saving treatment, not financial gain.
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A New Blueprint For Transforming Feasibility And Recruitment9/22/2025
Discover how a connected approach links feasibility and recruitment, using real-world data to design realistic protocols, reach the right patients, and accelerate enrollment with confidence.
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Global e-Consent Matrix3/9/2026
Navigate complex regional regulations and identity requirements to modernize your global clinical trial enrollment. Ensure compliance and access while moving toward digital participant engagement.
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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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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
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Reframing Clinical Vendor Selection7/2/2025
Explore a platform that enables seamless vendor selection as well as cross-functional collaboration with built-in templates and tailored question libraries that simplify proposal creation and review.
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How A Rare Disease Biotech Replaced Manual Processes With RTSM Software3/26/2026
Discover how a clinical-stage biotech automated its supply chain to protect patient enrollment and eliminate manual errors in a complex, multi-national genetic medicine trial.
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Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments2/3/2025
A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
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Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
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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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Removing Translation Bottlenecks With AI8/8/2025
See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.
NEWSLETTER ARCHIVE
- 05.21.26 -- The U.S. Clinical Trial Recruiting Pipeline Report – May 2026
- 05.20.26 -- The Legal Consequences Of AI In Clinical Research
- 05.20.26 -- STREAM Edition: Regulatory Compliance And Trusted AI
- 05.19.26 -- Is It Time To Replace RECIST — Or Just Add AI?
- 05.18.26 -- Reinterpreting Belmont For Contemporary 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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![CTD story - GettyImages-1253880092 and Canva]( "How Did You End Up In Clinical Research?")
To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"
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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.
-
![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.
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.
-
![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.
