Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.
- Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial
- Clinical Trials Need Fewer Barriers And More Humans
- Forget More Clinical Tech, We Need More Adoption
- Breaking Through Tumor Defenses With Next-Generation Cell Therapy
- Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic
- Joe Dustin: Sites Are Driving Clinical Tech Evolution
- Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease
GUEST COLUMNISTS
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![Dietitian holding diet plan-GettyImages-1425188874]( "The Problem With Excluding Children From GLP-1 Trials In The U.S.")
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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![Various Pills on White Stripes of American Flag-GettyImages-172849908]( "U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact")
U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement ImpactBeroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.
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![Woman using smartwatch-GettyImages-2248203064]( "How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows")
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial WorkflowsLearn 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.
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![Female nurse working at hospital-GettyImages-1333203074]( "4 Steps For Representative Enrollment In Rare Disease Trials")
4 Steps For Representative Enrollment In Rare Disease TrialsDiscover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.
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![Smart Chips, AI-GettyImages-1326193256]( "When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs")
When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROsLearn how to account for AI-related costs under evolving U.S. Generally Accepted Accounting Principles (GAAP).
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![FDA]( "FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now")
FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do NowOn December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.
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![AI, Holographic AI chip interface with European Union flag-GettyImages-2244741422]( "How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)")
How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.
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![European Union AI Act hologram-GettyImages-2244742120]( "How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)")
How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.
CLINICAL TRIAL WHITE PAPERS
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![Bioprocess Pharma Vial GettyImages-1130423724]( "Empowering Mid-Size Pharma Companies With Integrated Drug Development, Regulatory Strategy, And AI Innovation")
Empowering Mid-Size Pharma Companies With Integrated Drug Development, Regulatory Strategy, And AI InnovationA consultative, tech-enabled CRO can help mid-size pharma achieve targets by supplementing skillsets, expanding global reach, and designing an effective clinical, regulatory, and operational strategy.
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A New Blueprint For Transforming Feasibility And Recruitment9/22/2025
Discover how a connected approach links feasibility and recruitment, using real-world data to design realistic protocols, reach the right patients, and accelerate enrollment with confidence.
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Navigating Adverse Immunostimulation: A Practical Guide For Clinical Researchers9/30/2025
Explore a systematic approach to evaluate adverse immunostimulation (AIS) in drug development through standardized biomarker sampling and tailored management strategies.
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Antibody-Drug Conjugates: 'Magic Bullets' Become Reality2/19/2025
Cancer therapy has evolved from potent chemotherapy to targeted biological therapy, including antibody-drug conjugates (ADCs). Learn more about ADCs’ makeup, mechanisms, and the development landscape.
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How Sponsors Can Drive Success With Central eSource At Investigator Sites6/17/2025
Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.
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Disclosure Management System: Build Or Buy?6/19/2025
Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Use Case: How Consulting & Analytics Can Guide Clinical Strategy7/10/2025
A large European pharmaceutical company sought to benchmark a CRO’s suggestions involving a Phase III trial for a newly acquired asset.
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Pay-By-Procedure Vs. Pay-By-Visit12/8/2025
Explore how a pay-by-procedure model can reshape site payments, enhance transparency, and reveal meaningful efficiencies across complex clinical trials.
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eCOA: Unified Approach Streamlines Processes, Speeds Start Up And Improves Data Quality5/8/2024
Discover how a leading biopharmaceutical company revolutionized its clinical development with an eCOA solution that optimized its processes, cut build times, and enhanced data quality.
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Preparing The Next Generation Of Clinical Research Professionals9/4/2025
Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.
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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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RTSM: Randomization And Cohort Management, IP Inventory Management4/17/2024
Signant’s SmartSignals® RTSM solution helped an innovative biopharmaceutical company secure an FDA Orphan Drug designation for its cardiomyopathy drug.
NEWSLETTER ARCHIVE
- 02.25.26 -- 4 Steps To Make A Business Case For Digital Endpoints
- 02.25.26 -- STREAM Edition: CRL Transparency Comes With Real Trade-Secret Risks
- 02.24.26 -- When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs
- 02.23.26 -- The U.S. Trial Advantage Is Eroding
- 02.21.26 -- The Case For Research-Naive PIs
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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![Dietitian holding diet plan-GettyImages-1425188874]( "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.
-
![Woman using smartwatch-GettyImages-2248203064]( "How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows")
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.
-
![Female nurse working at hospital-GettyImages-1333203074]( "4 Steps For Representative Enrollment In Rare Disease Trials")
Discover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.
FOCUS ON PATIENTS
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![Father playing with child-GettyImages-1567083882]( "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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![Dietitian holding diet plan-GettyImages-1425188874]( "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.
-
![Woman using smartwatch-GettyImages-2248203064]( "How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows")
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.
