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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Direct-To-Patient RTSM Solution
Explore modern decentralized trials that bring the supply chain into the patient experience. and including the pros and cons of direct-to-patient models.
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Cell And Gene Therapy Field Quiet In Q28/15/2024
While there weren't any new gene or cell therapy approvals in Q2 2024, the U.S. approved two RNA therapies: Rytelo, an oligonucleotide telomerase inhibitor, and mRESVIA, an mRNA vaccine.
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Global Vaccine Clinical Trials: Australia's Strategic Advantage10/14/2025
The global vaccine clinical trials landscape presents unprecedented opportunities. This report analyses emerging trends, regional opportunities, and Australia’s distinctive strengths in vaccine development.
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Unique IRT Implementation Considerations For Personalized Medicine Trials8/22/2025
The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.
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A Strategic Guide For Biotech And Biopharma Leaders5/15/2025
Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.
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Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As?10/20/2025
Noncompliance with clinical trial disclosure regulations can jeopardize M&A deals. Understanding FDA and SEC requirements is critical to avoid red flags during due diligence.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Expanding Accessibility In A Phase 3 Influenza Study Through Community-Based Research10/6/2025
By meeting participants where they are, this study sets a new benchmark for inclusive, efficient, and impactful vaccine development.
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Digitizing And Standardizing Participant Pain Body Maps6/13/2024
Explore how digitizing clinical trial processes, such as paperless "body map" assessments, can enhance efficiency and standardization in pharmaceutical trials.
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Examining A Phase 1 COVID-19 Clinical Trial5/10/2024
Uncover how we were able to efficiently activate the site and enroll 130 participants within six months, demonstrating our expertise in clinical trial management.
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Achieving A 2.67x Reduction In Study Build Time For An Innovative Neuromodulation Study12/20/2024
This study explores the potential of Focused Ultrasound Neuromodulation in deepening meditative states, and the platform that helps enhance the overall experience for researchers and participants alike.
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Reducing The Burden Of Patient Retention And Improving Continuity1/6/2026
Immunology trials often place a sustained burden on participants. However, integrating Home Trial Support (HTS) into a Phase 3 immunology trial can help improve the overall study experience.
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.