From feasibility inefficiencies to overdesigned trials and overloaded investigative sites, the conversations at SCOPE were thoughtful and candid. The problem isn’t ignorance. It’s execution. Until simplification shows up in shorter timelines, leaner protocols, and measurable relief for sites, we may continue gathering each year to discuss the same issues — with the same data.
- These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials
- Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
- What ChatGPT Ads Will Really Mean For Clinical Trials
- The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?
- The Key Role Of Clinical Supply Teams In Patient Centricity Efforts
- Informed Consent Isn't Broken — But It's Barely Working
- Pharma Procurement Can Make Or Break Startups: Let's Help Mature Our Future Partners To Secure Innovation
GUEST COLUMNISTS
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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.
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![Standing out from the crowd-GettyImages-2228630235]( "Becoming A Backbone Therapy: Lessons Learned With Actuate Therapeutics")
Becoming A Backbone Therapy: Lessons Learned With Actuate TherapeuticsCEO 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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![Medical examination of woman using ultrasound equipment of liver kidneys-GettyImages-1482783655]( "Building Patient Trust In Research Through Connection Driven-Transparency")
Building Patient Trust In Research Through Connection Driven-TransparencyThe 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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![Noon Mission-GettyImages-698778782]( "How To Lead A Moonshot Collaboration: Lessons From Over A Decade Of Competitors Working Together")
How To Lead A Moonshot Collaboration: Lessons From Over A Decade Of Competitors Working TogetherTransCelerate BioPharma's Andy Lee and Janice Change share the lessons they learned bringing disparate voices together for a united purpose.
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![Healthcare Questions-GettyImages-2193936936]( "Patient Trust In Pharma Is Low; Here's How To Rebuild It")
Patient Trust In Pharma Is Low; Here's How To Rebuild ItCISCRP's Annick de Bruin and Shalome Sine provide strategies for building patient trust based on the findings from their Perceptions & Insights Study.
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![American Flag-GettyImages-2256012795]( "The U.S. Trial Advantage Is Eroding")
The U.S. Trial Advantage Is ErodingOnce the go-to location for trials, the U.S. is now seeing competition from APAC, driven by political, economic, and workforce pressures domestically and rapid growth abroad.
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![Machine learning, ai, aertificial intelligence-GettyImages-2216092983]( "Making AI Safety Routine: How Sites And Sponsors Can Continuously Monitor Clinical AI")
Making AI Safety Routine: How Sites And Sponsors Can Continuously Monitor Clinical AILearn why the next frontier in AI governance will involve real-time surveillance of algorithmic performance across institutions with guidance from Akshaya Bhagavathula and Michelle A. Williams.
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![Lessons Learned-GettyImages-835037356]( "Want To Optimize Clinical Project Team Performance? Try This Formal 'Lessons Learned' Process")
Want To Optimize Clinical Project Team Performance? Try This Formal 'Lessons Learned' ProcessLearn how a formal "lessons learned" process can help teams work collaboratively with open, honest, and timely communication to reach thoughtful decisions that lead to on-time, on-budget, and inspection-ready trials.
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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Breaking Through Barriers With Integrated Trial Optimization5/9/2025
In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.
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Ensuring A Diverse Patient Population In Clinical Trials12/13/2024
In 2025, the FDA will require pharmaceutical companies to include diversity action plans (DAPs) for Phase II and pivotal studies.
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2025 Safety And Regulatory Compliance Trends And Predictions12/16/2024
Explore the rapidly evolving regulatory landscape that pharmaceutical and biotech industries face as they integrate AI and advanced technologies into safety, compliance, and lifecycle management.
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Powering More Efficient Clinical Development With AI And ML7/7/2025
Explore how AI and ML are revolutionizing clinical trials by automating data processes to accelerate research and transform data into actionable outcomes for patient care.
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Accelerate Precise Medical Coding In Clinical Trials2/16/2024
Learn how the algorithm behind Rave Coder+, a next-generation medical coding solution, revolutionizes medical coding in clinical trials, offering unparalleled efficiency and precision.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How Compassion Shaped This Pediatric Rare Disease Trial6/11/2025
Learn how kindness transformed the clinical trial experience for pediatric rare disease participants in a global study.
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A Community-Focused Approach To Metabolic Disease Trials8/28/2024
Learn how innovative strategies like free health exams, community engagement, and a comprehensive patient database helped this project achieve rapid enrollment with a high level of patient diversity.
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CRO Takes Trial Build Times From Weeks To Days5/27/2025
Recognizing the inefficiencies in traditional build processes, a top global CRO partnered with Medable to transform its approach to clinical trial launch.
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CRO Uses CRIO eSource To Double Monitoring Productivity1/31/2025
Examine the transformative impact of eSource technology on monitoring productivity during a global Phase 3 trial conducted by a Contract Research Organization (CRO) amid the COVID-19 pandemic.
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Medable's Japanese Clinical Trial Exceeds FPI Date And eCOA Adherence3/10/2025
A top-10 global pharma company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites in Japan. Explore an initiative to enhance the patient and site experience.
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Study Analysis – Site Payment Automation12/8/2025
By removing administrative bottlenecks, see how automation improves cash flow for sites, reduces operational burden for sponsors, and supports smoother, more predictable trial execution.
NEWSLETTER ARCHIVE
- 02.12.26 -- What CROs Do Right Isn't Always Obvious To Research Sites
- 02.11.26 -- Clinical Supply's Role In Driving Success In Decentralized Trials
- 02.11.26 -- STREAM Edition: Engage Early With The FDA On AI
- 02.10.26 -- 3 Clinical Research Attorneys Talk 2026 Trends
- 02.09.26 -- Why The EU Biotech Act Matters To The U.S.: A Clinical Perspective
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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![advertising on social media-GettyImages-2201068162]( "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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![Medical examination of woman using ultrasound equipment of liver kidneys-GettyImages-1482783655]( "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.
-
![Healthcare Questions-GettyImages-2193936936]( "Patient Trust In Pharma Is Low; Here's How To Rebuild It")
CISCRP's Annick de Bruin and Shalome Sine provide strategies for building patient trust based on the findings from their Perceptions & Insights Study.
FOCUS ON PATIENTS
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![Return On Investment, growth-GettyImages-2224140598]( "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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![Fun while washing hands-GettyImages-2217454730]( "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")
Clinical supply decisions shape patient access, safety, and trial success. From logistics to procurement, patient-centric supply can accelerate therapies or quietly delay them.
