As FDA timelines and AI-enabled development accelerate, biopharma’s biggest bottleneck may be its own ability to make earlier, cross-functional decisions.
- 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
- The U.S. Clinical Trial Recruiting Pipeline Report – June 2026
- Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And Efficiency
GUEST COLUMNISTS
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![Partnership or teamwork-GettyImages-658833916]( "Delays At The Handoff: Where Breakdowns Occur Among The Sponsor, CRO, And Site")
Delays At The Handoff: Where Breakdowns Occur Among The Sponsor, CRO, And SiteConsultant 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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![Lab Experiment-GettyImages-157697835]( "The U.S. Clinical Trial Recruiting Pipeline Report – June 2026")
The U.S. Clinical Trial Recruiting Pipeline Report – June 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 May 1 to June 30, 2026.
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![hand closing valve on gas pipeline-GettyImages-1450250263]( "Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And Efficiency")
Pharma R&D Pipeline Productivity: Three Ways To Enhance Bandwidth And EfficiencyPA Consulting's Naveed Panjwani explores how to improve pipeline productivity via resource utilization, tech-enabled operations, and execution discipline.
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![navigating the future of healthcare-GettyImages-1785706755]( "Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over Volume")
Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over VolumeTransCelerate 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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![Business finance-GettyImages-1503371245]( "The Cost And ROI Of Agentic AI In Clinical Trials: What Sponsors And CROs Need To Know")
The Cost And ROI Of Agentic AI In Clinical Trials: What Sponsors And CROs Need To KnowBeroe 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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![Biological cancer cell disease-GettyImages-2161692091]( "Unlocking Gentler, Cost-Efficient TIL Therapy For Cold Tumors")
Unlocking Gentler, Cost-Efficient TIL Therapy For Cold TumorsCuraCell 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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![Online testing, questionaire, voting-GettyImages-873499310]( "What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory Confidence")
What Pistoia Alliance's AI Poll Reveals About Industry Readiness And Regulatory ConfidencePistoia 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.
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![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
Early Patient Education And Community Outreach Are Advancing Representation In Clinical TrialsMerck 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.
CLINICAL TRIAL WHITE PAPERS
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![digitize documents, ai chat-GettyImages-1608823234]( "If Data Integrity Matters, Paper Is Not An Option")
If Data Integrity Matters, Paper Is Not An OptionDitch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.
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UK Clinical Trial Regulations Reform7/24/2026
UK trial regulations have been overhauled. Learn what faster approval pathways, stricter publication rules, and longer retention requirements mean for your operations.
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The True ROI Of Decentralized Clinical Trials11/13/2025
Gain 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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Disclosure Management System: Build Or Buy?6/19/2025
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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Sickle Cell Cure Within Reach, But At A Steep Cost7/10/2025
Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.
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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Overcoming Unexpected Obstacles In A Phase 1 Study1/29/2025
Discover how the implementation of mobile vision clinics (MVCs) was used to enhance efficiency in a Phase 1 clinical trial.
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Leveraging A Demand-Led Clinical Supply Model For Program-Level Product Pooling3/12/2026
See how a global biopharmaceutical company was able to address inefficiencies and reduce waste within the clinical supply chain for a high-value therapy that faced strong demand but limited supply.
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How Cara Therapeutics Increased Compliance And Reduced Study Team Burden7/31/2025
Delve into the partnership that helped Cara Therapeutics achieve a significant milestone in their clinical research efforts to transform the lives of chronic pruritus patients.
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Inspection Facilitation Without Local MAH Presence5/26/2026
Local expertise and centralized oversight ensured compliant, well‑coordinated inspections across countries, reducing operational risk and client burden while maintaining consistent authority engagement.
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Use Case: A Patient-Centric Approach To Site Selection1/27/2025
Discover how Citeline’s robust datasets, combined with real-world data, inform intelligent site and investigator selection for a rare, autoimmune disease.
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Accelerating CRO Study Deployment At Scale7/7/2025
A top-3 CRO and a top-10 pharmaceutical company partnered with Medable to help accelerate, scale, and standardize their eCOA trials. See how they accomplished it.
NEWSLETTER ARCHIVE
- 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
- 07.28.26 -- When One Trial Leads To Rethinking Them All
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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![Inefficiency, delays, confusion, public administration-GettyImages-2213159033]( "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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![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
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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![Finance, data-GettyImages-2253914965]( "5 Informed Consent Fixes For Sponsors And Investigators")
Informed consent has never been solely about documentation, but some sponsors has treated it as a checkbox exercise. Here, consultant Tasha Mohseni shares tips and fixs for how best to approach informed consent.
FOCUS ON PATIENTS
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![Busy surgery waiting room-GettyImages-1208597148]( "Early Patient Education And Community Outreach Are Advancing Representation In Clinical Trials")
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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![MRI_forPR_final-(4)-(1)]( "Digital Twins Enhance Disease Progression Measurements In FSHD")
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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![kaniel_cassady_01_edit_stairs]( "How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients")
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.
