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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![trends-for-2025-GettyImages-2161094939]( "The Patient Recruitment Shift: Navigating Disruption, Delivering Precision")
The Patient Recruitment Shift: Navigating Disruption, Delivering PrecisionExplore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.
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Five Ways Centralized Trial Finance Improves Site And Patient Satisfaction6/15/2026
Centralizing payments and logistics improves transparency, accelerates reimbursements, and supports better site performance and patient retention in clinical trials.
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eSource Purpose Is Not Just To Complete The EDC7/7/2025
Central eSource transforms data capture from a passive, back-end chore into an active, real-time quality and compliance engine—delivering benefits that extend beyond faster EDC feeds and reduced SDV.
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Outlook Good For 7 Drugs Up For Q3 Review8/15/2024
A total of 24 drugs, devices, diagnostics, and deals are expected to progress in the third quarter of 2024, including approval applications for 17 drugs. The estimated overall likelihood of approval is 90% or higher for seven of those drugs, including revumenib for acute myelogenous leukemia and KarXT for schizophrenia.
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If Data Integrity Matters, Paper Is Not An Option3/5/2026
Ditch 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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Best Practices In Rare Disease Patient Recruitment3/9/2026
Recruiting for rare disease clinical trials is daunting, and making patients aware of clinical trials, involving them in trial design, and building trust are a few ways sponsors can boost recruitment.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Navigating Choppy Waters: Rapid Study Completion For An Anti-Nausea Compound7/17/2026
See how strategic technology reuse and real-time query resolution allow study teams to successfully manage high-volume, rapid participant enrollment without compromising data quality.
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Powering Complex Personalized Medicine Oncology Trial2/25/2026
Managing custom therapies requires a synchronized supply chain. Learn how to bridge the gap between manufacturing and clinical workflows to ensure seamless patient care in complex oncology trials.
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Setting A New Client Standard In Study Closeout Timelines4/4/2025
Learn how a top-10 global pharmaceutical company achieved a significantly faster time to market for a high-profile therapy.
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Sol-Gel Builds Awareness Of Rare Skin Condition, Generates Leads4/1/2026
Explore a 60-day HCP Awareness email campaign that surpassed industry benchmarks and generated a substantial number of leads.
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Partnership Driving Superior Enrollment And Speed In Phase III Trial1/31/2025
Examine the partnership between CRIO and Sitero, including how it underscores the significant impact of technology in optimizing trial performance and accelerating treatment development.
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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.
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.
