To secure long-term innovation, Ascendis Pharma's Ivanna Rosendal suggests pharma companies should help startup companies through their growing pains.
- How To Lead A Moonshot Collaboration: Lessons From Over A Decade Of Competitors Working Together
- Patient Trust In Pharma Is Low; Here's How To Rebuild It
- Why Dr. Robert Califf Isn't Pulling His Punches Anymore
- The U.S. Trial Advantage Is Eroding
- Making AI Safety Routine: How Sites And Sponsors Can Continuously Monitor Clinical AI
- Want To Optimize Clinical Project Team Performance? Try This Formal 'Lessons Learned' Process
- 4 Factors Changing The Way CRAs Monitor Trials
GUEST COLUMNISTS
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Want To Optimize Clinical Project Team Performance? Try This Formal 'Lessons Learned' Process
Learn 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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4 Factors Changing The Way CRAs Monitor Trials
The way CRAs monitor is about to change. Regeneron's Patrick Floody discusses these four factors that will influence it.
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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.
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Too Little Info, Too Much Time Wasted: Feasibility Challenges For Sites
Incomplete protocols, lengthy sponsor decision timelines, and uncompensated work plague clinical research sites. Learn why these issues exist and how to address them alongside experts from SCRS and Tufts CSDD.
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Will New AI Health Assistants Suggest Clinical Trials To Inquiring Patients?
New AI health assistants are now doing even more to help patients make sense of symptoms, diagnoses, and treatment options. What does that mean for the discoverability of clinical trials?
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What CROs Do Right Isn't Always Obvious To Research Sites
CROs are doing many things right. But it's when that right thing is understood — not just executed — that the impact becomes far greater than compliance alone.
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How Gilead Includes Patients Most Affected By HIV In Its PrEP Trials
VP of Clinical Development, HIV, Moupali Das shares how the sponsor approaches diverse participant recruitment and enrollment, highlighting the importance of early demographic research and careful, intentional PI selection.
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3 Clinical Research Attorneys Talk 2026 Trends
Three life sciences legal experts share what they see happening in the year ahead — and what should remain firmly in the past.
CLINICAL TRIAL WHITE PAPERS
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Modernizing Clinical Trial Oversight: The Path To Clinical Operations Excellence
Examine the current state of RBQM approaches to virtualizing clinical oversight, and the value that adopting these approaches brings to sponsors, CROs, sites, and ultimately patients.
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Deriving Reliable Clinical Outcome Scores From Continuous DHT Data6/10/2025
DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.
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Triple-Negative Breast Cancer: Global Clinical Trial Landscape1/30/2025
With over 1,500 TNBC-focused clinical trials since 2019, research efforts into Triple-negative breast cancer (TNBC) treatments are accelerating despite challenges such as drug resistance.
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Sickle Cell Cure Within Reach, But At A Steep Cost7/10/2025
Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.
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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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How Digitized Protocols Are Accelerating Clinical Research4/15/2025
Digitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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eCOA: Unified Approach Streamlines Processes, Speeds Start Up And Improves Data Quality5/8/2024
Discover how a leading biopharmaceutical company revolutionized its clinical development with an eCOA solution that optimized its processes, cut build times, and enhanced data quality.
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Innovation Under Pressure: Navigating Clinical Trials Amid a Pandemic7/23/2024
How do you complete a Phase 2b rheumatology study in three countries despite global lockdowns? Palleos cracked the code, achieving recruitment targets and regulatory approvals against all odds.
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Vaccine Trial Sees >90% eCOA Adherence5/1/2024
Discover how we addressed vaccine trial challenges and drove remarkable success, achieving over 90% adherence to eCOA, ensuring active engagement from the trial participants, and yielding consistent, reliable trial data.
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A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
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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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Optimized Processes: A Guide To Lyophilization Cycle Development6/25/2024
Review the essential phases of the lyophilization cycle — freezing, primary drying, and secondary drying — and critical success factors to achieve optimal product quality and stability.
NEWSLETTER ARCHIVE
- 02.06.26 -- 4 Factors Changing The Way CRAs Monitor Trials
- 02.06.26 -- Pave The Way To Clinical Trial Operation Success
- 02.05.26 -- What To Watch For In The 2026 Clinical Trial Landscape
- 02.04.26 -- Is Your Team Burnt Out? Discover The ROI Of Healthy Employees Running Trials
- 02.04.26 -- STREAM Edition: Data Cleaning And Site Performance
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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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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CISCRP'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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Once 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.
FOCUS ON PATIENTS
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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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CISCRP'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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VP of Clinical Development, HIV, Moupali Das shares how the sponsor approaches diverse participant recruitment and enrollment, highlighting the importance of early demographic research and careful, intentional PI selection.