Taking another angle to the FDA focus on psychedelic research, Enveric Biosciences CEO Joseph Tucker, Ph.D., explores what the FDA’s moves mean for non-hallucinogenic drug sponsors.
- The Patient Advocacy Strategy Behind Skyhawk's Rapid Enrollment
- How FDA Alignment Is Shaping Opus Genetics' OPGx-LCA5 Development Strategy
- Why Vendor Oversight Breaks Down At Handoffs
- Don't Accept This Site-Level Start-Up Bottleneck— Instead, Learn How To Stop It
- Rebecca Jackson: EHR-To-EDC Needs A Reality Check
- What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care
- July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
GUEST COLUMNISTS
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![GettyImages-2233249181_bloodwork]( "What It Takes To Validate A Biomarker For Real-World, Post-Transplant Care")
What It Takes To Validate A Biomarker For Real-World, Post-Transplant CareYelena Bushman, MBA, VP of cell therapy and transplant at CareDx, discusses the operational challenges of validating biomarkers for post-transplant care.
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![pills spill on 100 dollar bill-GettyImages-826130422]( "July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing")
July Update — U.S. Generic Drug Tariffs: Implications For Pharma And OutsourcingMathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
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![c suite changes]( "C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain Injury")
C-Suite Changes Help Biotech Narrow Focus But Maintain Drive To Treat Fatal Neonatal Brain InjuryNewly-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.
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![Data storage archive-GettyImages-1164612248]( "3 Ways To Solve Data Friction In Modern Clinical Data Management")
3 Ways To Solve Data Friction In Modern Clinical Data ManagementSenior clinical data manager Shasidar Reddy Abbidi shares how to reduce data friction with targeted automation, early standards adoption, and clearer workflows that move data to decisions faster.
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![AI powered search Engine-GettyImages-2215176753]( "How Visible Is Your Clinical Trial To AI?")
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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![bottleneck, searchscope-GettyImages-2166479887]( "Threat From Within: Why Biopharma's Drug Development Bottleneck Is Systemic")
Threat From Within: Why Biopharma's Drug Development Bottleneck Is SystemicAs FDA timelines and AI-enabled development accelerate, biopharma’s biggest bottleneck may be its own ability to make earlier, cross-functional decisions.
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![GettyImages-1826452239_data]( "Beyond Task Tracking: Why ClinOps Needs Dependency Intelligence")
Beyond Task Tracking: Why ClinOps Needs Dependency IntelligenceClinical trial operations will always need task tracking, but they're not enough on their own. Dependency intelligence shifts the focus toward readiness not reaction.
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![Backpain-GettyImages-512749727]( "To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome Measures")
To Take On Transverse Myelitis, Researchers Must First Address Heterogeneity And Misguided Outcome MeasuresUNC researcher Irena Dujmovic Basuroski, MD, Ph.D., discusses why transverse myelitis remains difficult to study, how multicenter collaboration and adaptive trial designs may help, and why better clinical, patient-reported, and biomarker-based measures are essential to advancing treatment.
CLINICAL TRIAL WHITE PAPERS
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![iStock-1205667168-meeting-presentation-group-discussion]( "Outlook Good For 7 Drugs Up For Q3 Review")
Outlook Good For 7 Drugs Up For Q3 ReviewA 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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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.
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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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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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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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Overcoming Challenges In Obesity Trials2/12/2026
Obesity trials face high dropout rates due to long durations and complex requirements. Overcome these hurdles with personalized engagement, expert lifestyle support, and proactive patient care.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How A Leading Chinese Biopharmaceutical Company Modernized Clinical Operations7/15/2026
A growing biopharma pipeline needed better document oversight. Learn how automation and centralized tracking improved compliance and trial visibility.
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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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Phase 1 Trial In Painful Diabetic Peripheral Neuropathy2/24/2026
A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.
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Maintain Compliance Through Divestiture Without Disrupting Operations6/25/2026
Facing a divestiture? Learn how to protect historical quality records and stay audit-ready throughout the transition.
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Biotech Delivers A Superior Patient And Site Experience3/4/2025
To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.
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Building A Scalable Oncology Engine In A Dynamic Market6/3/2026
Learn how a top-10 global pharmaceutical company partnered with Medable to rapidly scale the number of oncology trials it could concurrently conduct.
NEWSLETTER ARCHIVE
- 08.12.26 -- Smarter Trials Don't Happen By Accident
- 08.12.26 -- eTechnologies Improving Trial Design And Execution
- 08.11.26 -- Rethink What Works In Clinical Trials: From Protocol Design To Digital Workflows
- 08.10.26 -- What Sponsors Don't See: The Systems Behind Clinical Trial Delivery
- 08.08.26 -- Clinical Leader Newsletter - Best Of July
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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![GettyImages-1362711093-growing-arrow-people-group]( "The Patient Advocacy Strategy Behind Skyhawk's Rapid Enrollment")
Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.
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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.
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.
