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
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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
-
![GettyImages-1284610189-laboratory-research-development-cell-culture]( "Sickle Cell Cure Within Reach, But At A Steep Cost")
Sickle Cell Cure Within Reach, But At A Steep CostTreatment 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.
-
Navigating The European Market's Regulatory Complexities12/30/2024
Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.
-
Unique IRT Implementation Considerations For Personalized Medicine Trials8/22/2025
The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.
-
The Patient Recruitment Shift: Navigating Disruption, Delivering Precision3/27/2025
Explore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.
-
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.
-
RWD, New Technologies Show Potential In Clinical Trial Recruitment7/10/2025
Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Finding An RTSM Software To Keep Up With A Small Biotech3/26/2026
Stop letting rigid RTSM builds stall your oncology trials. Learn how agile configuration and right-sized documentation keep Phase I studies on track during frequent protocol amendments.
-
Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan2/7/2025
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
-
Enhance DMC Services By Harnessing Biostatistics Expertise8/7/2024
Discover how expert biostatistics and project management ensured data integrity and efficient DMC operations in a complex clinical trial for hematologic cancer cell therapies.
-
FastChain®: A Solution For Made-To-Order Gene Replacement Therapy Study3/12/2026
Adopt a demand-led clinical supply strategy to reduce waste, optimize limited product supply, and accelerate patient access across global clinical trials.
-
What Unified eCOA And IRT Can Unlock4/6/2026
See how real-time scoring and automated eligibility checks helped a global dermatology study reduce site burden, avoid manual errors, and move participants through screening with greater speed.
-
Strategic Implications Of The Single Phase 3 Approval Paradigm7/21/2026
As FDA single-trial approvals gain traction, CNS developers need stronger early evidence. Learn how biomarkers, patient selection, and regulatory strategy can accelerate development.
NEWSLETTER ARCHIVE
- 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
- 07.27.26 -- Optimizing The Clinical Lifecycle: Evaluating Site Models, Unlocking Social RWD, And Elevating Representation
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.
-
![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.
-
![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
-
![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.
-
![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.
-
![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.
