The FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.
- The Uncomfortable Conversation: AI And Data Use In Clinical Trials
- When A Clinical Trial Surfaces In An AI Chat, What Happens Next?
- Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
- Pick The Right PV Technology With Help From A Safety Data Management Expert
- Tekton's CEO On The Growing Power Of Site Networks
- The Cost Of Transactional Thinking In Clinical Research
- Say It Loud: Clinical Research Needs New Voices
GUEST COLUMNISTS
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Safe And Sustainable DCTs and Hybrid Trials (Part 2)
In part two of this series, learn practical cloud architectural patterns, governance structures, and operating mechanisms that allow sponsors to run hybrid and decentralized trials.
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Why Sponsors Should Share KPI Rationale With Sites
To build partnerships, foster transparency, and promote shared accountability, Curo Research CEO Amy Bland explains why sponsors need to communicate the utility of KPIs with sites.
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Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial
Alterity Therapeutics CEO David Stamler shares how early diagnosis, biomarker-guided design, and precise patient selection positively impacted a trial in multiple system atrophy (MSA).
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Breaking Through Tumor Defenses With Next-Generation Cell Therapy
Ernexa Therapeutics CEO Sanjeev Luther shares how clinical research has revealed why certain cancers resist treatment and how emerging cell therapies may help break through those defenses.
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Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic
Pilatus Biosciences CEO Raven Lin shares learnings from his company's early-stage oncology program.
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Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease
The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
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The Problem With Excluding Children From GLP-1 Trials In The U.S.
In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
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U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
CLINICAL TRIAL WHITE PAPERS
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A Guide To Streamlining Study Start-Up In Australia
Discover the benefits of Australia as a premier destination for multinational sponsors looking to expedite drug development, refine trial design, and establish long-term research partnerships.
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Best Practices For Internal Quality Audits In Life Sciences3/14/2025
Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.
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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.
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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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Master Protocols: Implementing Effective Treatment Adaptations8/25/2025
From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.
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Digital Endpoint Resource Guide: Neuromuscular Disorders3/15/2024
Find out how sensor-based digital health technologies (DHTs) offer direct, objective daily life assessments, accelerating NMD drug development.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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.
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RTSM And Clinical Drug Dispensation7/16/2024
A pharma company used Signant Health's RTSM solution in a Phase 2 schizophrenia trial to ensure drug availability, maintain study balance, prevent duplicate allocations, and manage returns and destruction of unused drugs.
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EU's New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?7/23/2024
The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.
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Streamlining Global Respiratory Trial Complexities With Robust Data Capture Strategy9/23/2025
Want to see how eCOA solutions can simplify patient-reported data capture and accelerate global trials? Explore implementation strategies, lessons learned, and measurable results.
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Drug-Drug Interaction Study On A Novel Cardiovascular Medication9/17/2024
Learn how Altasciences leveraged its expertise to design, recruit, and conduct complex DDI studies, assessing pharmacokinetic and pharmacodynamic impacts of co-administered drugs.
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Reducing The Burden Of Patient Retention And Improving Continuity1/6/2026
Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.
NEWSLETTER ARCHIVE
- 03.04.26 -- Forget More Clinical Tech, We Need More Adoption
- 03.04.26 -- STREAM Edition: We Can't Really Interpret R3 In A Vacuum
- 03.03.26 -- How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows
- 03.02.26 -- Sites Are Driving Clinical Tech Evolution
- 02.27.26 -- Site Management And Oversight Become Must-Haves For Successful Sites
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 is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
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In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
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Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.
FOCUS ON PATIENTS
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The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
-
In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
-
Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.