Minovia Therapeutics shares the importance of careful site selection, specialized operational expertise, multidisciplinary collaboration, and innovative trial design as it prepares for pivotal this year.
- 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
- Becoming A Backbone Therapy: Lessons Learned With Actuate Therapeutics
- Building Patient Trust In Research Through Connection Driven-Transparency
- How To Lead A Moonshot Collaboration: Lessons From Over A Decade Of Competitors Working Together
GUEST COLUMNISTS
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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.
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![Number 4-GettyImages-1458365060]( "4 Factors Changing The Way CRAs Monitor Trials")
4 Factors Changing The Way CRAs Monitor TrialsThe way CRAs monitor is about to change. Regeneron's Patrick Floody discusses these four factors that will influence it.
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![Business Quality Assurance and Compliance-GettyImages-2225358412]( "How Can AI Change Computerized System Validation?")
How Can AI Change Computerized System Validation?Learn how AI technologies are changing the computer system validation (CSV) landscape and what you need to understand about this transformation.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1483611679-computer-cloud-digital-files-hands-keyboard]( "How Digitized Protocols Are Accelerating Clinical Research")
How Digitized Protocols Are Accelerating Clinical ResearchDigitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.
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How Can Digital Measures Advance Heart Failure Research?2/27/2024
Wearable DHTs offer a less burdensome means of collecting data on physical activity, mobility, and sleep patterns, all of which are crucial indicators in heart failure management.
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Gene Therapies For Rare Diseases: Platforms, Modalities, And Delivery Systems10/6/2025
Examine the treatment landscape for rare diseases and the rapid evolution of gene therapy across three key dimensions: editing platforms, delivery modalities, and delivery vehicles.
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Paper Vs ePRO: Clinical Data Collection Methods7/16/2024
Patient-reported outcomes (PROs) assess patients' health without clinician interpretation. Traditional paper methods often result in missing data and quality issues, while electronic solutions enhance data accuracy and completeness.
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Navigating The European Market's Regulatory Complexities12/30/2024
Prepare your EU launch strategy with this comprehensive guide detailing what is needed to ensure compliance and efficiency in the EU market.
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Digital Endpoint Resource Guide: Neuromuscular Disorders3/15/2024
Find out how sensor-based digital health technologies (DHTs) offer direct, objective daily life assessments, accelerating NMD drug development.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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Post-Market Safety And Risk Management in DMD4/11/2025
The pharmaceutical company specializing in rare neurological diseases sought solutions after encountering significant hurdles in post-market safety surveillance.
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Expanding Diabetes-Related Eye Health Equity1/29/2025
20/20 Onsite, American Diabetes Association and Genentech collaborated on an event to provide immediate diagnostic services, including retinal imaging and visual acuity assessments, directly on-site.
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Digital Biomarkers Show Pathway To Reduced Study Sample Sizes, Shorter Durations7/8/2024
Digital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.
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Community Engagement vs. Digital Engagement For Higher Enrollment8/28/2024
Explore the importance of tailoring recruitment strategies to specific populations and leveraging diverse channels to reach potential participants.
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Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot8/19/2024
Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.
NEWSLETTER ARCHIVE
- 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
- 02.06.26 -- 4 Factors Changing The Way CRAs Monitor 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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![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.
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![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.
