Forced to cease using Anthropic's Claude for its Elsa generative AI assistant, the FDA is switching to Gemini. Legal experts Kimberly Chew, Esq., and Michael Yang, Esq., explain the implications for trade secrets and data security risks.
- Do We Still Need To "Save" Our Sites?
- When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down
- How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026
- The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development
- Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
- Avoid Clinical Alignment Breakdowns With "Lateral Agility"
- Why Africa Could Be The Next Frontier For Clinical Trials
GUEST COLUMNISTS
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![business, teamwork,collaboration-GettyImages-922937404]( "Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes")
Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything ChangesThe outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.
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![Risk protection, business and life-GettyImages-1872872331]( "The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board")
The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On BoardTufts CSDD’s Beth Harper shares findings from the org's latest Impact Report and discusses how companies might better define risk, measure success, and understand central monitoring.
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![bayesian stats image-GettyImages-1205583077]( "FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs")
FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small BiotechsThe FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.
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![Climate Change-GettyImages-2151025853]( "Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial")
Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology TrialDiscover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.
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![AI-Artificial Intelligence in Healthcare-GettyImages-1365534802]( "The Uncomfortable Conversation: AI And Data Use In Clinical Trials")
The Uncomfortable Conversation: AI And Data Use In Clinical TrialsAI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.
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![Chat bot service, future marketing-GettyImages-1468141962]( "When A Clinical Trial Surfaces In An AI Chat, What Happens Next?")
When A Clinical Trial Surfaces In An AI Chat, What Happens Next?AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
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![Contracting, signing business investment-GettyImages-1370104932]( "The Cost Of Transactional Thinking In Clinical Research")
The Cost Of Transactional Thinking In Clinical ResearchDenise 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.
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![Medical cloud technology, digital healthcare data storage, data management-GettyImages-2204263083]( "Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)")
Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1208552262 elderly, patient, telehealth]( "The Real-Time Monitoring Dilemma")
The Real-Time Monitoring DilemmaBalance the need for offline data safety with the necessity of real-time monitoring. Learn how to navigate new regulatory requirements for source devices while maintaining high patient compliance.
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Empowering Transformation Through Technology4/24/2024
By outlining the transformation of clinical data management into data science, this paper highlights the growing responsibility of data managers as stewards of all clinical trial data and its overall quality.
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Real-Time Clinical Data Insights Delivered By Automation And AI2/26/2026
Automated data flows and human‑guided AI enable faster, more reliable oversight into clinical trials. Learn how real‑time insights and unified monitoring support quality, efficiency, and readiness.
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Clinical Trial Starts Rose At Slower Pace In 202412/8/2025
Clinical trial starts grew 5.5% to 10,503 in 2024, a slowdown from 2023’s 9.4% rise in trial starts. Sustained geopolitical and global regulatory pressures on pharma contributed to curbing momentum.
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The Future Of Regulatory Operations6/3/2024
The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.
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ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations11/21/2025
Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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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Overcoming Unexpected Obstacles In A Phase 1 Study1/29/2025
Discover how the implementation of mobile vision clinics (MVCs) was used to enhance efficiency in a Phase 1 clinical trial.
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Analytics–Powered Approach To Patient Recruitment Strategy7/15/2025
In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.
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Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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GxP Inventory Delivers Real-Time Visibility, Operational Efficiency11/17/2025
Modernize your clinical supply chain to streamline global trial operations, ensure regulatory compliance, and deliver investigational therapies to patients efficiently and reliably.
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Rare Disease Prioritization Model And Landscape Analysis3/15/2024
Uncover how a global pharmaceutical company seeking to identify promising indications among rare diseases to develop preclinical candidate molecules received an in-depth disease analysis to guide its strategic decision-making.
NEWSLETTER ARCHIVE
- 03.12.26 -- Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
- 03.11.26 -- Mobile Health Exhibit Bringing Clinical Trial Education To Communities
- 03.11.26 -- STREAM Edition: Policy By Press Release Is Now A Real Problem
- 03.10.26 -- When A Clinical Trial Surfaces In An AI Chat, What Happens Next?
- 03.09.26 -- Expanding Influenza Study Access Via Community-Based Research
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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![Affordable care act-GettyImages-1148533483]( "How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment")
The relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.
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![Chat bot service, future marketing-GettyImages-1468141962]( "When A Clinical Trial Surfaces In An AI Chat, What Happens Next?")
AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
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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.
FOCUS ON PATIENTS
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![Traffic light over urban intersection-GettyImages-1168877430]( "Patient-Powered Drug Trials Are Getting The FDA Greenlight")
Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.
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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.
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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.
