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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![clinical-compliance-GettyImages-2259718661]( "10 Clinical Research Practices That Feel Like Compliance (But Aren't)")
10 Clinical Research Practices That Feel Like Compliance (But Aren't)Many clinical research routines are driven by habit, not regulation. This guide clears up 10 common misconceptions to streamline workflows and reduce unnecessary admin work.
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New Duke Research Shows Participants Prefer Enhanced eConsent10/7/2024
It’s apparent to those who have used it that the “e” in eConsent could stand for much more than 'electronic'. Duke’s new research shows why participants prefer an eConsent experience bolstered with videos, media, questions, and more.
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Modernizing Clinical Trial Logistics To Deliver Value2/3/2026
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
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Pharma R&D Annual Review Supplement: New Active Substances4/15/2026
Last year was by some distance the best year ever in terms of new active substances. Explore the 105 new debuts that easily outstrips that of the previous record holder, 2021’s, 97.
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Addressing Trial Design Hurdles Across Alzheimer's Disease Stages12/10/2025
Explore how endpoint selection, rater training, and the strategic implementation of eCOA can help address the unique scientific, operational, and human considerations at each stage of AD.
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Agentic AI And How It's Impacting Clinical Trial Research7/7/2025
Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Metabolic Disorders Clinical Trial Case Study9/17/2024
Check out this case study to learn how partnering with an accomplished contract research organization is essential in the complex and dynamic field of metabolic drug development.
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How To Seamlessly Integrate NetSuite With Power BI8/12/2024
Unlock the power of your NetSuite data with seamless integration to Power BI. Learn how to automate data refresh, gain real-time insights, and make informed business decisions.
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Medable's Japanese Clinical Trial Exceeds FPI Date And eCOA Adherence3/10/2025
A top-10 global pharma company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites in Japan. Explore an initiative to enhance the patient and site experience.
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Accelerating A Schizophrenia Trial While Ensuring Quality7/31/2026
Tight timelines and rising patient targets don't have to derail a trial. See how speed and data quality can work together from enrollment to database lock.
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Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
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Breaking Free From Process Paralysis In Clinical Trials1/13/2025
Explore the implementation of CRIO’s eSource solution by a leading pharmaceutical company to overcome process paralysis in clinical research.
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.
