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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5 Essential Capabilities For Decentralized Clinical Trials
Learn how to develop and utilize a successful DCT framework, enabling your study to enhance patient access, improve data quality, and streamline study operations.
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2025 Trends In Patient Recruitment: From Disruption To Precision3/27/2025
Explore the four macro trends reshaping the recruitment space in 2025—each grounded in emerging data, technology, and behavior shifts.
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Hepatitis B - Global Clinical Trial Landscape3/6/2025
As Hepatitis B virus (HBV) clinical trials advance, refining therapeutic endpoints and integrating novel treatment strategies are essential to transforming Hepatitis B management.
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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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De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital9/3/2025
For early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
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Optimizing Site Activation To Accelerate Clinical Trials6/5/2025
Clinical trial site activation delays are a major bottleneck in drug development, hampering trial timelines and funding flows. To reverse this trend, site-focused solutions are being prioritized.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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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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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Relieving The Strain Of Publishing During Regulatory Registration8/7/2024
Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.
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How Pfizer Used Wearable DHTs To Reveal Meaningful Treatment Effects In Cancer Cachexia11/20/2024
Wearable digital health technologies (DHTs) played a crucial role in assessing patient-centric outcomes during pfizer's study into the benefits of using ponsegromab for treating cancer cachexia.
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Metabolic Disorders Clinical Trial Case Study9/17/2024
Check out this case study to learn how partnering with an accomplished contract research organization is essential in the complex and dynamic field of metabolic drug development.
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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.
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.