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
- Beyond Task Tracking: Why ClinOps Needs Dependency Intelligence
- 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
GUEST COLUMNISTS
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![GettyImages-2208609448_business]( "4 Hidden Gaps In Clinical Trial Preparation For Small Biotechs")
4 Hidden Gaps In Clinical Trial Preparation For Small BiotechsGaps are not always visible at the executive level, but their consequences are very real — affecting timelines, budgets, data quality, and ultimately the likelihood of regulatory success.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1485186476_obesity]( "Digital Endpoint Resource Guide: Obesity And Related Metabolic Disorders")
Digital Endpoint Resource Guide: Obesity And Related Metabolic DisordersExplore how digital health technologies can enhance obesity treatment by providing critical insights beyond weight loss.
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A Guide To Digital Endpoints In Major Depressive Disorder3/7/2025
The integration of digital health technologies (DHTs) in clinical trials for Major Depressive Disorder (MDD) is transforming how symptom severity and treatment efficacy are measured.
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A Smartphone Based Biomarker For The Estimation Of Unipolar Depression Severity3/28/2025
The study investigates the potential of using smartphones and wearables to create objective biomarkers for mood disorders, specifically focusing on unipolar depression.
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Challenges, Opportunities For Recruitment In The Digital Age10/20/2025
Health literacy gaps and online misinformation hinder clinical trial recruitment. Meeting patients where they are — digitally and educationally — can improve engagement and enrollment success.
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Understanding Immunogenicity In AAV Gene Therapy8/14/2025
As adeno-associated virus-based gene therapies progress toward clinical use, effectively managing immunogenicity risk is critical to patient selection, therapeutic durability, and regulatory success.
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Transforming Effective Patient Recruitment Within The Changing Health Care Landscape2/6/2026
Revolutionize 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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Advancing Immunotherapy In Head And Neck Cancer: The IT-MATTERS Study4/17/2025
This randomized controlled pivotal Phase 3 study evaluated efficacy and safety of neoadjuvant complex biologic administered for three consecutive weeks pre-surgery.
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Quantitative ROI With DCTs11/13/2025
Through dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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A Mission To Expand Recruitment Territory6/11/2026
Learn how a proactive feasibility approach helps sponsors strengthen enrollment forecasting, mitigate risk, and implement timely interventions that improve study execution and clinical development.
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Post-Market Safety And Risk Management in DMD4/11/2025
The pharmaceutical company specializing in rare neurological diseases sought solutions after encountering significant hurdles in post-market safety surveillance.
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Study Analysis – Site Payment Automation12/8/2025
By removing administrative bottlenecks, see how automation improves cash flow for sites, reduces operational burden for sponsors, and supports smoother, more predictable trial execution.
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Streamlining Pediatric Clinical Trials With Vestigo®5/8/2026
Utilizing a centralized, automated platform can eliminate the friction of manual accountability logs, ensuring audit readiness while providing real-time visibility into financial reporting.
NEWSLETTER ARCHIVE
- 08.06.26 -- Development With Orphan Drug Designation And Early Talks With The FDA
- 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
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.
