The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
- U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact
- How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows
- 4 Steps For Representative Enrollment In Rare Disease Trials
- When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs
- 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
GUEST COLUMNISTS
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![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.
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![European Union AI Act hologram-GettyImages-2244742120]( "How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)")
How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.
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![numbers, finance-GettyImages-2169186276]( "These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials")
These Four Things Are Helping Minovia Therapeutics' Rare Disease TrialsMinovia Therapeutics shares the importance of careful site selection, specialized operational expertise, multidisciplinary collaboration, and innovative trial design as it prepares for pivotal this year.
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![Return On Investment, growth-GettyImages-2224140598]( "Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment")
Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse EnrollmentTwice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.
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![advertising on social media-GettyImages-2201068162]( "What ChatGPT Ads Will Really Mean For Clinical Trials")
What ChatGPT Ads Will Really Mean For Clinical TrialsAI 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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![Fun while washing hands-GettyImages-2217454730]( "The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?")
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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![Manager checking expiration dates in drugstore-GettyImages-1666055443]( "The Key Role Of Clinical Supply Teams In Patient Centricity Efforts")
The Key Role Of Clinical Supply Teams In Patient Centricity EffortsClinical 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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![Working hard for success-GettyImages-2201479298]( "Pharma Procurement Can Make Or Break Startups: Let's Help Mature Our Future Partners To Secure Innovation")
Pharma Procurement Can Make Or Break Startups: Let's Help Mature Our Future Partners To Secure InnovationTo secure long-term innovation, Ascendis Pharma's Ivanna Rosendal suggests pharma companies should help startup companies through their growing pains.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-912073314 In Home Nurse]( "Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps")
Continuous Cough Monitoring: Addressing Placebo Effects And Data GapsModernizing symptom monitoring is essential to improving clinical trial quality, and these tools deliver richer, more accurate data that can help close information gaps.
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Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress7/15/2025
Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.
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Digital Biomarker Upholds Adherence, User Satisfaction, Validity3/25/2024
Digital biomarkers, smartphones, and wearables are transforming clinical trials by enabling remote data collection and offering insights into treatment efficacy. Discover how these exploratory endpoints enhance confidence in clinical trials.
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Best Practices For Harmonizing Global Data Disclosure2/20/2024
Learn how sponsors can address the challenge of submitting clinical trial data in a consistent and compliant manner by examining internal processes to identify and close gaps.
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Accelerate Drug Development With Master Protocols5/15/2025
Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
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PV Solutions Optimizing End-To-End Safety In Clinical Development3/6/2024
Explore what the future of PV services and technology in the life sciences industry could look like if innovation, regulatory vigilance, and collaboration with regulatory bodies were prioritized.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Increasing Efficiency And Reducing Drug Waste10/2/2025
Discover how streamlined clinical supply chain management helped accelerate study timelines, reduce costs, and support global treatment delivery through a strategic technology partnership.
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Paperless Online Remote Source Document Verification2/2/2026
Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.
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Optimizing Kitting For Cell Therapy Trials In Pediatric Oncology5/2/2025
Precision for Medicine’s Kitting team played a crucial role in overcoming this challenges of a Phase I multicenter pediatric cell therapy trial targeting relapsed or refractory solid tumors.
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Delivering Specialist Neurology Support4/17/2025
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
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Driving A High-Adherence LTFU Trial Without An EDC10/29/2025
Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.
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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.
NEWSLETTER ARCHIVE
- 02.19.26 -- Could Moving To This Swiss Life Sciences Hub Be In Your Company's Future?
- 02.18.26 -- Making Medical Innovation Matter To Patients With Simplified Trial Design
- 02.18.26 -- STREAM Edition: Empower Efficient Clinical Study Execution
- 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
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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![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.
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![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.
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![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
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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.
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![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.
