Deep learning is reshaping clinical trial design, execution, and analysis. Learn how to deploy it safely, measurably, and at scale with help from life sciences consultant and MIT industry advisor Partha Anbil.
- Avoid Clinical Alignment Breakdowns With "Lateral Agility"
- Why Africa Could Be The Next Frontier For Clinical Trials
- The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board
- FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs
- How Keenova Reignited A Stalled Trial
- 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
GUEST COLUMNISTS
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The Uncomfortable Conversation: AI And Data Use In Clinical Trials
AI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.
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When A Clinical Trial Surfaces In An AI Chat, What Happens Next?
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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The Cost Of Transactional Thinking In Clinical Research
Denise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.
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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.
CLINICAL TRIAL WHITE PAPERS
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Phase 1 Clinical Trial Designs And Strategies
With tailored guidance, sponsors can align their modern model-based and model-assisted design choices to program goals, accelerating progress while safeguarding patients.
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Wearables For Optical Cardiovascular Monitoring6/10/2025
Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).
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Site Perspectives On BYOD ePRO Use6/17/2024
This study examines participant convenience and compliance, aiming to understand and address the challenges faced by site personnel in global trials.
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Patient-Reported Outcome In Oncology Clinical Trials4/17/2025
As cancer therapies grow more complex and personalized, patient-reported outcomes (PROs) have emerged as a vital component of oncology research and care.
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Powering More Efficient Clinical Development With AI And ML7/7/2025
Explore how AI and ML are revolutionizing clinical trials by automating data processes to accelerate research and transform data into actionable outcomes for patient care.
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Automated Evidence Generation For Regulatory-Grade RWD10/20/2025
Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Accelerating Approval Pathway For Phase III Ovarian Cancer Trial8/29/2025
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
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The Perfect Solution For Recruitment, Retention, And ROI8/15/2024
See how Citeline Connect was deployed to advance enrollment six months ahead of schedule for a sponsor’s Phase IV atopic dermatitis trial and build a community of engaged patients.
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Use Of Epiontis ID In A Phase 2 Psoriasis Trial9/25/2025
Mirikizumab’s Phase 2 trial explores IL-23 inhibition in psoriasis, measuring immune cell changes to assess its potential for long-term disease control and flare-up prevention.
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Transforming Clinical Trial Sites With Research Study Rockstar2/10/2025
This innovative platform addresses prevalent pain points faced by trial coordinators by streamlining workflows, automating patient communication, and providing intuitive dashboards that simplify trial management.
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Delivering A Registrational GI Trial Through Ongoing Protocol Shifts10/17/2025
A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.
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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.
NEWSLETTER ARCHIVE
- 03.09.26 -- Expanding Influenza Study Access Via Community-Based Research
- 03.06.26 -- How Regulatory Convergence Is Rewriting Clinical Data Management
- 03.06.26 -- Clinical Trial Software And eClinical Solutions
- 03.05.26 -- How To Lead A Moonshot Collaboration
- 03.05.26 -- Scaling Clinical Trials Without Losing Control
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.
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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.