ImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for agressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.
- 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
- When One Trial Leads To Rethinking Them All
- The Cost And ROI Of Agentic AI In Clinical Trials: What Sponsors And CROs Need To Know
- Reduce Friction And Save Time: Revamp Site Training To Focus On Value Over Volume
GUEST COLUMNISTS
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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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![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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![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.
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![woman receiving cancer treatment-GettyImages-1346190289]( "The Promise Of Bispecifics In The Quest For Outpatient Immunotherapy")
The Promise Of Bispecifics In The Quest For Outpatient ImmunotherapySTART San Antonio's Drew Rasco, MD, reflects on the evolution of immunotherapy and highlights how novel therapies such as bispecifics are both challenging and intriguing for principal investigators (PIs).
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![MRI_forPR_final-(4)-(1)]( "Digital Twins Enhance Disease Progression Measurements In FSHD")
Digital Twins Enhance Disease Progression Measurements In FSHDDigital 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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![Finance, data-GettyImages-2253914965]( "5 Informed Consent Fixes For Sponsors And Investigators")
5 Informed Consent Fixes For Sponsors And InvestigatorsInformed 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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1146439597 data, research, tablet]( "The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event Detection")
The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event DetectionA proven, AI-powered safety platform can accelerate adverse event detection and safety data extraction to ease the burden on safety professionals and better protect patients.
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What Clinical Trial Decision Makers Are Prioritizing In 20255/7/2025
In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.
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Bringing Clinical Trials To Everyone's Backyard1/10/2025
Learn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
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How Early-Stage Planning Strategies Are Optimizing Drug Development5/12/2025
Early integration of a target product profile (TPP) into early-stage planning is pivotal for steering drug development toward both regulatory success and commercial impact.
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Digital Endpoint Resource Guide: Parkinson's Disease8/20/2024
Explore how sensor-based digital health technologies can revolutionize the treatment and management of movement disorders by providing more accurate, patient-centered outcomes.
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Writing An IND Module 3 For Cell And Gene Therapy Products9/1/2025
This whitepaper outlines the critical considerations for CGT Investigational New Drug (IND) Module 3, as well as how to avoid clinical holds and ensure regulatory readiness.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Reinventing Prostate Cancer Diagnostics With An All-In-One Platform3/31/2026
Discover how a lean research team saved an estimated $100k and reached 95% data compliance by unifying their clinical workflow.
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Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning1/31/2025
The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.
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Recruitment To Screening: Bridging The Gap12/5/2025
Explore how providing tracked transportation for patients can streamline recruitment, improve site conversion rates, and deliver measurable ROI for clinical trials.
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Case Management Accelerates Shipment For SCN1A+ Dravet Syndrome Gene Therapy3/12/2026
Consider this streamlined, end-to-end solution that helped safeguard study timelines and ensured that patients with urgent medical needs could receive treatment without delay.
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Maintain Compliance Through Divestiture Without Disrupting Operations6/25/2026
Facing a divestiture? Learn how to protect historical quality records and stay audit-ready throughout the transition.
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Continuity And Risk Mitigation Following Unexpected QPPV Resignation5/26/2026
Rapid escalation and clear interim governance ensured compliance and operational continuity following an unexpected QPPV resignation, reducing inspection risk during a critical pharmacovigilance transition.
NEWSLETTER ARCHIVE
- 07.28.26 -- When One Trial Leads To Rethinking Them All
- 07.27.26 -- Optimizing The Clinical Lifecycle: Evaluating Site Models, Unlocking Social RWD, And Elevating Representation
- 07.24.26 -- Turning RWD Into RWE That Works For Trials
- 07.23.26 -- The Profit Margin Double Standard That Needs To Change
- 07.22.26 -- Bridging The CGT Patient Gap, Endpoint Gaps, And Trial Friction
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.
-
![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.
