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.
- FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now
- SCOPE Takeaways On Inclusion And Real Patient-Centricity
- My SCOPE Groundhog Day Experience
- How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)
- How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)
- These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials
- Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
GUEST COLUMNISTS
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Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.
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What ChatGPT Ads Will Really Mean For Clinical Trials
AI health assistants may be used to surface clinical trials earlier in patient journeys, and advertising inside conversational AI is best understood as the next logical step in that same progression.
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The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?
Despite the size and visibility of the community — and the call for diverse patient research — there remains a gap in available health data specific to the Sikh community in the U.S.
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The Key Role Of Clinical Supply Teams In Patient Centricity Efforts
Clinical supply decisions shape patient access, safety, and trial success. From logistics to procurement, patient-centric supply can accelerate therapies or quietly delay them.
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Pharma Procurement Can Make Or Break Startups: Let's Help Mature Our Future Partners To Secure Innovation
To secure long-term innovation, Ascendis Pharma's Ivanna Rosendal suggests pharma companies should help startup companies through their growing pains.
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Becoming A Backbone Therapy: Lessons Learned With Actuate Therapeutics
CEO Dan Schmitt discusses the pursuit of a backbone therapy and how Actuate's current and planned trials are structured to confirm that potential.
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Building Patient Trust In Research Through Connection Driven-Transparency
The question is not whether trust matters but how industry, sponsors, and investigators can bridge the trust gap to drive patient participation.
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How To Lead A Moonshot Collaboration: Lessons From Over A Decade Of Competitors Working Together
TransCelerate BioPharma's Andy Lee and Janice Change share the lessons they learned bringing disparate voices together for a united purpose.
CLINICAL TRIAL WHITE PAPERS
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Blueprint For Early Phase Clinical Pharmacology Studies In Dermatology
Explore the landscape of dermatological drug development through a comprehensive framework for rational early-phase dermatological trials, centered around five foundational pillars.
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The Real Cost In CNS Trials: Rater Drift And Site Readiness11/21/2025
Learn how to build resilience into CNS trial operations with evidence-based frameworks that prioritize human factors alongside digital tools.
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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.
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Cell And Gene Therapy Field Quiet In Q28/15/2024
While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
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Digital Endpoint Resource Guide: Obesity And Related Metabolic Disorders8/15/2024
Explore how digital health technologies can enhance obesity treatment by providing critical insights beyond weight loss.
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Digital Endpoint Resource Guide: Parkinson's Disease8/20/2024
Explore how sensor-based digital health technologies can revolutionize the treatment and management of movement disorders by providing more accurate, patient-centered outcomes.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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.
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Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice10/30/2024
See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.
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AI In Clinical Data Management: How Does It Work?8/18/2024
AI is revolutionizing clinical data management by automating medical coding, data reconciliation, and audit trail reviews, significantly enhancing efficiency and accuracy.
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Advancing Neuromuscular Research with Digital Endpoints1/20/2026
Explore cutting-edge digital measures that capture peak mobility and activity in real-world settings, offering meaningful insights into disease progression in neuromuscular disorders.
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Data Key In Addressing Patient Recruitment Challenges6/19/2025
Explore how a Phase II trial for extensive-stage and previously treated small cell lung cancer overcame recruitment challenges with a data-driven solution designed to surface protocol-matched patients.
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Recruiting & Retaining More Patients Per Site:3/14/2025
Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
NEWSLETTER ARCHIVE
- 02.17.26 -- Digital Protocols Are At An Inflection Point
- 02.16.26 -- Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
- 02.14.26 -- Best Of January
- 02.13.26 -- Continuous Evidence Generation Remains Critical To Vaccine Development
- 02.13.26 -- Find A Consulting Partner To Boost Your Clinical Trials
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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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.
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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.
FOCUS ON PATIENTS
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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.
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Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.