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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![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.
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![bechtel getz series article 2]( "Too Little Info, Too Much Time Wasted: Feasibility Challenges For Sites")
Too Little Info, Too Much Time Wasted: Feasibility Challenges For SitesIncomplete 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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![digital platform, artificial intelligence, machine learning, processing for mental health-GettyImages-2234202465]( "Will New AI Health Assistants Suggest Clinical Trials To Inquiring Patients?")
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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![Diverse business team-GettyImages-2198573359]( "What CROs Do Right Isn't Always Obvious To Research Sites")
What CROs Do Right Isn't Always Obvious To Research SitesCROs 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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![friends laughing-GettyImages-1488926575]( "How Gilead Includes Patients Most Affected By HIV In Its PrEP Trials")
How Gilead Includes Patients Most Affected By HIV In Its PrEP TrialsVP 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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![tablet with number 2026-GettyImages-2245485086]( "3 Clinical Research Attorneys Talk 2026 Trends")
3 Clinical Research Attorneys Talk 2026 TrendsThree 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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![GettyImages-1463515619 home visit nurse]( "The True ROI Of Decentralized Clinical Trials")
The True ROI Of Decentralized Clinical TrialsGain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
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How AI Is Reshaping Trial Design, Execution, And Disclosure9/25/2025
AI has quietly embedded itself into the operational heart of clinical development, where it is accelerating decisions, reducing manual burden, and improving outcomes.
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Chronic Lymphocytic Leukemia: Global Clinical Trial Landscape (2024)8/19/2024
CLL is slow-progressing leukemia primarily affecting older adults. Get the latest information on research, innovative therapies, and emerging clinical trials shaping CLL care by downloading this report.
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Radiation Therapy Quality Assurance In Clinical Trials8/22/2024
Here, the authors describe the crucial role of radiation therapy in oncology trials and how a robust quality management program can enhance treatment outcomes and research efficacy.
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Master Protocols: Implementing Effective Treatment Adaptations8/25/2025
From balancing treatment ratios and managing eligibility to accommodating site-specific readiness and protocol amendments, a well-designed IRT system enables seamless transitions.
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Completed Clinical Trials Continued To Climb In 20246/19/2025
Data collected in this report reflects a shift toward sustained growth, reflecting rapid advancement in therapeutic areas such as oncology, autoimmune/inflammation, and central nervous system studies.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Building A High-Quality IND From Scratch With Strategic Gap Analysis8/12/2025
A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).
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EHR-To-EDC Success In A Complex, Adaptive Platform Trial4/17/2025
I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.
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Optimizing EDC Strategy And Data Collection for a Rare Disease Trial6/11/2025
Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.
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Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
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How To Recruit 236 Patients In An Osteoarthritis Study On Time During The Peak Of The Pandemic7/23/2024
A leading Eastern European contract research organization completed the recruitment of 236 subjects in a Phase 3 osteoarthritis study for Handok Inc. despite hurdles caused by the COVID-19 pandemic.
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Patient Caregiver Network Improves Post-Seizure Trial Data3/26/2024
Discover how a pharmaceutical CRO addressed concerns about seizure diary timing in a rare disease study, leveraging insights from Medable's Patient Community Network to optimize data collection.
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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![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.
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![American Flag-GettyImages-2256012795]( "The U.S. Trial Advantage Is Eroding")
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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![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.
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![friends laughing-GettyImages-1488926575]( "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.
