Newly-appointed leaders at ReAlta Life Sciences discuss their skill sets, their goals for advancing a therapy for hypoxic ischemic encephalopathy (HIE), and how they keep momentum as they strive to help bring this potentially lifesaving therapy to market.
- The Rare Trials Summit Wants To Produce More Than Conversation
- Threat From Within: Why Biopharma's Drug Development Bottleneck Is Systemic
- 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
- 4 Hidden Gaps In Clinical Trial Preparation For Small Biotechs
- ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies
- Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy
GUEST COLUMNISTS
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![pharmacist checks inventory, drug shelves-GettyImages-1941443650]( "ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive Malignancies")
ImvivaBio's Trial For Off-The-Shelf CAR-T Strategy For Aggressive MalignanciesImvivaBio CMO Jan Davidson-Moncada, MD, Ph.D., discusses the company's Phase 1b/2 study for aggressive T-cell malignancies, explaining their unmet need, the rationale for an allogeneic approach, and how they plan to address immune rejection.
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![Money, finance, economic value-GettyImages-2271167891]( "Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor Strategy")
Clinical Trial Per-Patient Cost Analytics For Procurement And Sponsor StrategyWith the help of Beroe Inc.'s Surya Ponnam, discover how per-patient cost (PPC) analytics is evolving into a core capability for balancing cost, quality, speed, and patient outcomes.
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![Cancer Outpatient During Chemotherapy IV Infusion-GettyImages-1263248921]( "Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer Patients")
Expanded Access And Rollover Design Help CytoDyn Reach High-Need Cancer PatientsCEO Jay Lalezari and CFO Robert E. Hoffman share how CytoDyn meet patient needs when they approach trial design for cancer trials.
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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")
Why Protocol Complexity Is Slowing First Patient In — And How Small Sponsors Can Fix Start-Up InefficienciesProtocol 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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![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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-953782406-digital-patients-people-recruit]( "Transforming Effective Patient Recruitment Within The Changing Health Care Landscape")
Transforming Effective Patient Recruitment Within The Changing Health Care LandscapeRevolutionize patient enrollment by closing the "95% gap." Explore an approach that uses digital health and data-driven insights to engage diverse populations where they live.
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Transforming Regulatory Processes Through AI, ML, NLP, And RPAs4/7/2025
Explore the rapidly evolving landscape of regulatory processes as they undergo a profound digital transformation, highlighting how emerging technologies are reshaping traditional regulatory frameworks.
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Wearables For Optical Cardiovascular Monitoring6/10/2025
Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).
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Implications Of Assessing Overall Survival In Oncology Studies3/25/2026
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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Proving The Return On Investment For eRegulatory1/22/2025
Explore a study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools … and then some.
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How Adaptive Design Accelerates Early‑Phase NSCLC Development5/22/2026
Adaptive trial designs and an adaptive mindset enable non-small cell lung cancer (NSCLC) sponsors to optimize dose, respond to evolving expectations, and accelerate early‑phase development.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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.
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Duchenne Muscular Dystrophy Trial In China9/17/2025
A global sponsor conducting a Duchenne Muscular Dystrophy trial in China required reliable patient travel solutions to support children and families.
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Reserving Data Integrity With Retrospective Manual Entry7/5/2026
A look at implementing randomization mid-trial by reconstructing subject and inventory records without disrupting sites or compromising data integrity.
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Enhance Access And Improve Retention In Rare Disease Trials With HTS4/17/2025
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
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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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How eSource Reduced Benchmark's Protocol Deviations By Almost 40%1/6/2025
Explore how a leading vaccine site network selected CRIO to help address the challenges with it's use of paper charts in collecting source data.
NEWSLETTER ARCHIVE
- 08.05.26 -- Decentralized, Flexible, Patient-First: The Future Of Clinical Trial Delivery
- 08.05.26 -- Every Stage Has Its Hurdles — Here's How Leading Teams Are Clearing Them
- 08.04.26 -- EHR Integration, Global Trial Payments, And Better CRF Validation
- 08.03.26 -- Patients Should Shape Trials Before Protocols Are Finalized
- 07.31.26 -- Are You Prepared? Risk Disclosure Insights For Clinical-Stage Firms
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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![AI powered search Engine-GettyImages-2215176753]( "How Visible Is Your Clinical Trial To AI?")
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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![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.
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.
