Tufts CSDD’s Beth Harper shares findings from the org's latest Impact Report and discusses how companies might better define risk, measure success, and understand central monitoring.
- Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial
- 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
GUEST COLUMNISTS
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Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)
Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.
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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.
CLINICAL TRIAL WHITE PAPERS
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Enhancing Clinical Trial Flexibility
Once seen primarily as staffing extensions, FSPs have evolved into strategic partners that deliver flexibility, scalability, and tailored expertise.
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State Of Clinical Trial Technology: The AI Inflection Point2/12/2026
Digital maturity gaps are widening in clinical research. Connected workflows speed insights and execution, while manual processes leave organizations increasingly behind.
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The Real Cost In CNS Trials: Rater Drift And Site Readiness11/21/2025
Learn how to build resilience into CNS trial operations with evidence-based frameworks that prioritize human factors alongside digital tools.
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ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations11/21/2025
Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.
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Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress7/15/2025
Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.
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Paper Vs ePRO: Clinical Data Collection Methods7/16/2024
Patient-reported outcomes (PROs) assess patients' health without clinician interpretation. Traditional paper methods often result in missing data and quality issues, while electronic solutions enhance data accuracy and completeness.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
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Enhance Access And Improve Retention In Rare Disease Trials With HTS4/17/2025
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
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Improving Clinical Trial Performance Through Central eSource10/23/2025
See how a top five pharmaceutical company leveraged our esource platform to enhance site performance, improve data consistency, and enable remote monitoring.
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How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives6/5/2024
Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.
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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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Automated Trial Monitoring Workflows Make A Lean Team More Efficient1/7/2026
A pharmaceutical therapy developer was looking to automate reports, confirmation letters, and follow-up letters. See what happened when they adopted a cloud-based solution for end-to-end trial management.
NEWSLETTER ARCHIVE
- 03.05.26 -- How To Lead A Moonshot Collaboration
- 03.05.26 -- Scaling Clinical Trials Without Losing Control
- 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
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.