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
-
![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.
-
![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.
-
![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.
-
![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.
-
![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.
-
![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).
-
![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.
-
![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
-
![GettyImages-486359855 business ipad hospital]( "eCOA Licensing Guide")
eCOA Licensing GuideIn this comprehensive guide, IQVIA's eCOA library and licensing specialists, Kayla Doyle and Piero Bindi, explore five essential steps for obtaining licenses for the assessments required in your clinical trial.
-
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.
-
Challenges, Opportunities For Recruitment In The Digital Age10/20/2025
Health literacy gaps and online misinformation hinder clinical trial recruitment. Meeting patients where they are — digitally and educationally — can improve engagement and enrollment success.
-
Global Trial Disclosure Landscape Grows Increasingly Complex4/15/2025
The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.
-
Closing The Gap In Our Understanding Of Sleep Health With DHTs4/26/2024
What is the current state of sleep assessments in clinical trials, regulatory expectations, and what opportunities do wearable digital health technologies present?
-
The True ROI Of Decentralized Clinical Trials11/13/2025
Gain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Supporting Study Set Up In Just 4 To 6 Weeks3/4/2025
Facing challenges in cycle times, quality control, and visibility, a global CRO adopted Medidata’s Rave Imaging, integrating it with its existing Rave EDC system to create a seamless digital workflow.
-
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.
-
End-To-End Inventory Control Supports Biotech's Expanding Portfolio2/19/2026
Many organizations struggle with siloed operations, but this modern GxP inventory solution solves these challenges by providing a centralized, cloud-based platform for end-to-end visibility.
-
Supporting Participants Through National Travel Disruptions12/10/2025
A sudden travel shutdown threatened a critical clinical visit. Rapid rescheduling, coordinated logistics, and clear communication ensured engagement and the ability to continue without interruption.
-
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.
-
Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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.
-
![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
-
![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.
