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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Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic
Pilatus Biosciences CEO Raven Lin shares learnings from his company's early-stage oncology program.
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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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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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U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
Beroe 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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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.
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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.
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When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs
Learn how to account for AI-related costs under evolving U.S. Generally Accepted Accounting Principles (GAAP).
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FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now
On 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.
CLINICAL TRIAL WHITE PAPERS
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The Importance Of A Maturity Model For Clinical Trial Transparency
A comprehensive maturity model for clinical trial disclosure and transparency offers companies a strategic tool to assess and enhance their practices in an increasingly complex regulatory environment.
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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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Streamlining Clinical Trial Start-Up In Australia10/20/2025
Gain a comprehensive overview of how sponsors can accelerate clinical trial start-up in Australia, leveraging the nation’s unique strengths as a global hub for clinical research.
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A 2025 Survey Report Uncovers The Top 5 Clinical Trial Cost Insights4/22/2025
In this 2025 survey of over 100 U.S. clinical trial participants and caregivers, we reveal that most individuals join trials seeking life-saving treatment, not financial gain.
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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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How Digitized Protocols Are Accelerating Clinical Research4/15/2025
Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Top Countries For Rescuing Your Clinical Study7/23/2024
When your study is in trouble, choosing the right country can help get it back on track. While many countries can and should be considered, palleos healthcare discusses the countries they have experienced with regard to clinical trial rescue.
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Expand Bandwidth With A Trusted Regulatory Writing Partner9/18/2025
Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.
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Automated Trial Monitoring Workflows Make A Lean Team More Efficient1/7/2026
A pharmaceutical therapy developer was looking to automate reports, confirmation letters, and follow-up letters. See what happened when they adopted a cloud-based solution for end-to-end trial management.
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Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments2/3/2025
A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
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Setting A New Client Standard In Study Closeout Timelines4/4/2025
Learn how a top-10 global pharmaceutical company achieved a significantly faster time to market for a high-profile therapy.
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Partnership Driving Superior Enrollment And Speed In Phase III Trial1/31/2025
Examine the partnership between CRIO and Sitero, including how it underscores the significant impact of technology in optimizing trial performance and accelerating treatment development.
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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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.
-
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.
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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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The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
-
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.
-
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.