Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.
- To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures
- From Signal To Strategy: What Oncology Basket Trials Can Teach Clinical Development Teams
- Inside ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive T-Cell Malignancies
- Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy
- Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients
- Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies
- Delays At The Handoff: Where Breakdowns Occur Among The Sponsor, CRO, And Site
GUEST COLUMNISTS
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Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up Inefficiencies
Protocol complexity directly affects timelines, costs, and execution quality. Consultant Jessica Cordes explains why this challenge requires sponsors to change their approach to protocol design, feasibility, and start-up.
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Delays At The Handoff: Where Breakdowns Occur Among The Sponsor, CRO, And Site
Consultant Jason C. Bork identifies 10 of the most common points at which a trial can break down before and after patient recruitment.
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The U.S. Clinical Trial Recruiting Pipeline Report – June 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 May 1 to June 30, 2026.
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Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And Efficiency
PA Consulting's Naveed Panjwani explores how to improve pipeline productivity via resource utilization, tech-enabled operations, and execution discipline.
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Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over Volume
TransCelerate BioPharma members Ashlin Dunne, Anne Marie Inglis, and Ann Katrine Miranda assess the state of site training, examine how training affects trial execution, and discuss a better path forward.
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The Cost And ROI Of Agentic AI In Clinical Trials: What Sponsors And CROs Need To Know
Beroe Inc. analyst T.G. Prasanna discusses agentic AI for clinical research and how it must be evaluated as a regulated operating cost transformation, with platform, orchestration, compliance, validation, and oversight costs modeled together.
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Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors
CuraCell Head of Clinical Operations Torbjörn Ström discusses, in the context of CC-38 and CytoPLY-derived tumor-infiltrating lymphocytes (TILs), the utility of named-patient experience, dosing and preconditioning, and T-cell therapy capabilities in cold solid tumors.
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What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory Confidence
Pistoia Alliance President Becky Upton, Ph.D., reviews findings from a poll about AI use in clinical research conducted at Clinical Trials Technology Congress (CTTC) that revealed barriers to adoption, early ROI, emerging use cases, and the role of patient-generated data.
CLINICAL TRIAL WHITE PAPERS
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Implications Of Assessing Overall Survival In Oncology Studies
New oncology standards mandate pre-specified survival analysis to catch long-term harm. Learn how to implement hazard ratio thresholds and the ICH E9(R1) framework for global compliance.
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State of Materiovigilance: Gaps, Technology & Outsourcing5/12/2026
Explore how pharma and biotech companies are using AI, outsourcing, and new technologies to strengthen materiovigilance for complex drug-device products.
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Human-Centered RTSM Design Enhances Data, Safety, And Operations12/5/2025
Uncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
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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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Safeguarding Personal Data: Protecting PII8/4/2025
Learn about a secure, patient-centric platform that enables individuals to participate in clinical trials and registries while maintaining lifelong access to their data.
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eSource Purpose Is Not Just To Complete The EDC7/7/2025
Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How A Biotech Startup Transformed Its Clinical Trial Supply Management2/25/2026
Don’t let your trial get lost in the shuffle of legacy vendors. See how a high-touch, consultative approach can protect your study’s future.
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GSK And Medable Discuss The Next Phase Of DCTs3/10/2025
GSK and Medable share the value of embedding DCTs into strategic goals to enhance trial accessibility, diversity, and efficiency.
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Accelerating Enrollment And Upholding Quality In Complex Oncology Trials5/5/2026
Real-world oncology trials reveal how fast physician engagement, hands-on biomarker management, and adaptive enrollment shorten timelines, reach first-patient milestones, and preserve data quality.
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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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Streamlining Phase 1 Trials With The Mobile Vision Pod1/29/2025
A contract research organization formed a partnership to address significant challenges during a Phase 1 clinical trial for a corneal disease treatment through the use of a Mobile Vision Pod.
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
NEWSLETTER ARCHIVE
- 08.03.26 -- Patients Should Shape Trials Before Protocols Are Finalized
- 07.31.26 -- Are You Prepared? Risk Disclosure Insights For Clinical-Stage Firms
- 07.30.26 -- What It's Like To Advance A Cell Therapy Through The Japan Entry Acceleration Program
- 07.29.26 -- Hybrid Models, Disease Modification, And Comparator Sourcing: This Week In Clinical Trials
- 07.29.26 -- STREAM Edition: The Cost Of Late Engagement — In AI, Regulatory, And Supply Chain
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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Ross Jacksons explores how clinical trials show up — it at all — in AI tools and what that means for sponsors' approach to publicizing trial information.
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Protocol complexity directly affects timelines, costs, and execution quality. Consultant Jessica Cordes explains why this challenge requires sponsors to change their approach to protocol design, feasibility, and start-up.
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Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
FOCUS ON PATIENTS
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Merck Executive Director, Clinical Trial Patient Representation, Adrelia Allen argues that patient awareness, access, early information, and trust shape are the pillars of patient representation in clinical trials.
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Digital twins can transform trial design by making data more robust and alleviating patient burden. In this interview, Epicrispr CEO Amber Salzman, Ph.D., shares how the company's using it to reliably predict muscle volume change in their trial for a FSHD gene therapy.
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Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.