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.
- Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)
- Why Sponsors Should Share KPI Rationale With Sites
- Safe And Sustainable DCTs and Hybrid Trials (Part 2)
- 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
GUEST COLUMNISTS
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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.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1282633951-laptop-man-suit-office-quality-management]( "Endpoint Clinical RTSM: Getting The Job Done")
Endpoint Clinical RTSM: Getting The Job DoneExplore how a Job-to-be-Done (JTBD)-focused RTSM approach reduces delays, optimizes costs, and accelerates trial success through predictive intelligence and streamlined global workflows.
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Overcoming Issues Of Non-Enrolling Sites In Clinical Trials1/14/2025
Explore the challenges of non-enrolling sites in clinical trials, focusing on the benefits of leveraging artificial intelligence (AI) and machine learning (ML) in addressing those issues.
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Digital Endpoint Resource Guide: Obesity And Related Metabolic Disorders8/15/2024
Explore how digital health technologies can enhance obesity treatment by providing critical insights beyond weight loss.
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Strategies For Post-Approval Lifecycle Management And Local PV7/12/2024
If you are unsure of how to navigate your post-approval regulatory journey, an experienced regulatory services partner can provide support to help you identify and achieve post-approval goals.
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What the FDA Looks For In Global Development Programs Today1/16/2026
Mastering the complexities of multi-regional clinical trials requires aligning global data with evolving regulatory expectations to ensure treatment consistency and successful drug approval.
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A Guide to Digital Endpoints in Respiratory Diseases4/15/2025
Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Accelerating CRO Study Deployment At Scale7/7/2025
A top-3 CRO and a top-10 pharmaceutical company partnered with Medable to help accelerate, scale, and standardize their eCOA trials. See how they accomplished it.
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Meeting 100% Recruitment 7 Months Ahead Of Schedule7/23/2024
Uncover the detailed outcomes of this extensive Phase 3 clinical trial on a new biosimilar for non-small cell lung cancer.
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Helping To Power The WHO Solidarity Trial Against COVID-193/21/2025
To overcome the unprecedented challenges of large-scale global clinical trials, adopting data capture solutions is essential for ensuring the success of critical research initiatives.
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Recruitment To Screening: Bridging The Gap12/5/2025
Explore how providing tracked transportation for patients can streamline recruitment, improve site conversion rates, and deliver measurable ROI for clinical trials.
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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.
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Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy9/25/2025
Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.
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.
-
![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.
