Featured Editorial
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How AI Can Accelerate Clinical Trials' Probabilities Of Technical And Regulatory Success (PTRS)
8/21/2025
AI expert Kelly H. Zou, Ph.D., explores how the technology can drive R&D successes, including clinical trials.
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Ask An Expert Before Shredding Your Mobile Device CAPEX
8/14/2025
Tasked with buying your company's mobile devices and not sure where to start? Discover the questions you should ask and the information you need to know before consulting an expert.
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Synthetic Control Arms: When Data Stands In For Patients
8/14/2025
Synthetic control arms replace traditional control groups with carefully matched historical or real-world data, offering an option for rare diseases, ethical constraints, or when high-quality datasets exist. They can speed access to treatments, but success depends on rigorous data matching, upfront planning, and early regulatory engagement.
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FDA's Elsa May Prompt Pharma To Rethink Regulatory Filings
8/13/2025
AI expert Pradeepta Mishra of Beghou Consulting explains why pharmaceutical companies need to quickly evolve their regulatory strategies, authoring procedures, and governance frameworks in light of the FDA's new Elsa generative AI pilot.
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Can Digital Endpoints Really Accelerate Clinical Trials?
8/8/2025
Digital biomarkers are quickly and quietly becoming the digital revolution needed to make clinical trials quicker and more data rich. Discover how they are being used in clinical trials right now.
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4 Clear Trends In Outsourced Clinical Services
8/4/2025
Discover the four dominant trends in outsourced clinical and eClinical services for 2025, with insights derived from an annual survey by L.E.K. Consulting.
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Paving The Way For Sites To Use Their Own Tech
7/17/2025
The DTRA has released a detailed playbook to help clinical research sites use their own validated technology in sponsor-led trials. The "Bring Your Own Technology" (BYOT) model aims to reduce tech overload at sites, improve efficiency, and preserve regulatory compliance — starting with eConsent as its first use case.
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Tufts & PACT Release New DCT Analysis
7/7/2025
We take a closer look at some of the key stats in a new DCT report from the Partnership for Advancing Clinical Trials (PACT), a consortium hosted and facilitated by the Tufts Center for the Study of Drug Development (CSDD).
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The Placeholder Debate: Why Teams Love (And Hate) This TMF Tool
7/7/2025
What is an eTMF placeholder? Why do some love it and some hate it? ICE Consulting's Suzanne Turner explains why there's such debate over their usefulness.
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Integrating QMS And eTMF For Proactive Clinical Trial Quality
6/24/2025
In today’s clinical trial landscape, where complexity is the new challenge, integration is not optional: QMS defines quality, and eTMF proves it.