The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.
- 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- FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs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
- When A Clinical Trial Surfaces In An AI Chat, What Happens Next?
- Pick The Right PV Technology With Help From A Safety Data Management Expert
GUEST COLUMNISTS
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![Contracting, signing business investment-GettyImages-1370104932]( "The Cost Of Transactional Thinking In Clinical Research")
The Cost Of Transactional Thinking In Clinical ResearchDenise 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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![Medical cloud technology, digital healthcare data storage, data management-GettyImages-2204263083]( "Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)")
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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![cloud data, cloud storage, digital health records, telemedicine technology-GettyImages-2253333942]( "Safe And Sustainable DCTs and Hybrid Trials (Part 2)")
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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![Hospital management meeting-GettyImages-1134045124]( "Why Sponsors Should Share KPI Rationale With Sites")
Why Sponsors Should Share KPI Rationale With SitesTo 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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![Parkinson's symptoms-GettyImages-1688988054]( "Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial")
Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA TrialAlterity 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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![GettyImages-1602744313 assay]( "Breaking Through Tumor Defenses With Next-Generation Cell Therapy")
Breaking Through Tumor Defenses With Next-Generation Cell TherapyErnexa 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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![Tumor Cancer Cells-GettyImages-2203606213]( "Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic")
Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The ClinicPilatus Biosciences CEO Raven Lin shares learnings from his company's early-stage oncology program.
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![Father playing with child-GettyImages-1567083882]( "Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease")
Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare DiseaseThe inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
CLINICAL TRIAL WHITE PAPERS
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![Business Meeting-GettyImages-1831418247]( "Accelerate Drug Development With Master Protocols")
Accelerate Drug Development With Master ProtocolsThrough careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
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How AI Is Reshaping Trial Design, Execution, And Disclosure9/25/2025
AI has quietly embedded itself into the operational heart of clinical development, where it is accelerating decisions, reducing manual burden, and improving outcomes.
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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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De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital9/3/2025
For early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
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Elevating Patient Centricity In Clinical Trials2/17/2025
How can the integration of patient perspectives throughout the clinical trial process enhance engagement and outcomes?
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Unique IRT Implementation Considerations For Personalized Medicine Trials8/22/2025
The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Drive Superior Enrollment, Speed, And Quality Using eSource1/3/2025
Explore a detailed analysis of 140 research sites involved in a Phase III trial, highlighting significant advancements in trial performance and data quality using CRIO’s eSource platform.
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How We Used Intelligent Automation to Transform Vendor Selection7/2/2025
Discover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.
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GxP Inventory Solution Delivers Real-Time Visibility, Operational Efficiency12/10/2025
Explore how unified forecasting and GxP-level inventory control can streamline your clinical supply chain, reduce risk, and strengthen oversight across every trial you run.
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Home Visit Nurses Deliver Complete Trial Data Despite A Challenging Population, A Pandemic And Severe Weather7/12/2024
Dive into the critical role of mobile nursing in maintaining trial integrity and participant engagement under unprecedented conditions in this Phase 3 clinical trial for Rett syndrome.
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Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology5/2/2025
Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.
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Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments1/29/2025
During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.
NEWSLETTER ARCHIVE
- 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
- 03.04.26 -- Forget More Clinical Tech, We Need More Adoption
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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![Chat bot service, future marketing-GettyImages-1468141962]( "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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![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.
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![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.
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.
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![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.
