Otsuka's Head of U.S. GPV Safety Data Management Vikalp Khare shares how smart governance should inform pharmacovigilance (PV) technology choices.
- Say It Loud: Clinical Research Needs New Voices
- Site-Centric First, Patient-Centric Always
- 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
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-1219551222-Patient-Person-Recruitment-Select]( "RWD, New Technologies Show Potential In Clinical Trial Recruitment")
RWD, New Technologies Show Potential In Clinical Trial RecruitmentLeveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.
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Sickle Cell Cure Within Reach, But At A Steep Cost7/10/2025
Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.
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The Rescue Option: Course Correcting Struggling Clinical Trials4/14/2025
The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.
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Completed Clinical Trials, Terminations Both Rose In 20236/13/2024
This white paper highlights how the widespread growth in completed trials is coupled with higher success rates across multiple therapeutic areas, signaling the end of pandemic-related disruptions and infectious disease-related activity after three years of fluctuations.
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Eliminate Clinical Trial White Space With The Right AI Strategy10/9/2025
Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.
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Modernizing Clinical Trial Logistics To Deliver Value2/3/2026
Explore how biopharma organizations can design and operate clinical supply systems that absorb complexity while maintaining control and consistency.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission1/27/2026
Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.
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Innovation Under Pressure: Navigating Clinical Trials Amid a Pandemic7/23/2024
How do you complete a Phase 2b rheumatology study in three countries despite global lockdowns? Palleos cracked the code, achieving recruitment targets and regulatory approvals against all odds.
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Data Matters: Accelerating Dermatology Research With Precision!7/23/2024
When deadlines are tight, execution matters. Find out how Palleos delivered critical data packages, statistical analysis, and regulatory-ready documentation—on time and with precision!
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Leading Recruitment With A Strong Alzheimer's Referral Pool And Clean Data2/24/2026
A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.
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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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Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning1/31/2025
The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.
NEWSLETTER ARCHIVE
- 02.27.26 -- Site Management And Oversight Become Must-Haves For Successful Sites
- 02.27.26 -- Overcoming Enrollment And Site Challenges
- 02.26.26 -- Why Dr. Robert Califf Isn't Pulling His Punches Anymore
- 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
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.
