TransCelerate BioPharma's Andy Lee and Janice Change share the lessons they learned bringing disparate voices together for a united purpose.
- 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
- Choosing Clinical Research … On Purpose
- How Can AI Change Computerized System Validation?
- Too Little Info, Too Much Time Wasted: Feasibility Challenges For Sites
GUEST COLUMNISTS
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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.
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![Business Risk Management-GettyImages-2151106988]( "The \"One-Trial\" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational Risk")
The "One-Trial" Trap: Why 2026's FDA Efficiency Push Actually Doubles Your Operational RiskWhen it comes to the FDA's new "one-trial" shift, researcher Johnathon Anderson, Ph.D., warns: Do not confuse efficiency with leniency. Here, Anderson offers three factors to consider when adapting to new FDA trial expectations.
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![Business performance evaluate checklist review-GettyImages-2150709873]( "Common Issues And Trends In Clinical Research Vendor Qualification")
Common Issues And Trends In Clinical Research Vendor QualificationDiscover the biggest challenges in vendor qualification, including this one misalignment that affected more than half of surveyed respondents.
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![Senior Man with Disability Reading Book-GettyImages-2244142906]( "\"Study Within A Study\" Reveals Best Recruitment Strategies For Alzheimer's Trials")
"Study Within A Study" Reveals Best Recruitment Strategies For Alzheimer's TrialsIn this Q&A, Acumen Pharmaceuticals shares findings from its Alzheimer's recruitment study, highlighting what efforts proved the most fruitful.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1483611679-computer-cloud-digital-files-hands-keyboard]( "Human-Centered RTSM Design Enhances Data, Safety, And Operations")
Human-Centered RTSM Design Enhances Data, Safety, And OperationsUncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
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Site Perspectives On BYOD ePRO Use6/17/2024
This study examines participant convenience and compliance, aiming to understand and address the challenges faced by site personnel in global trials.
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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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5 Essential Capabilities For Decentralized Clinical Trials2/3/2025
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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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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Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry7/8/2025
Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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6 Key Ways Real-World Data Is Accelerating Breast Cancer Therapies2/3/2025
Real-world data (RWD) is increasingly vital for advancing breast cancer research, and leveraging TA datasets allows researchers and clinicians to address pressing challenges.
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RTSM And Clinical Drug Dispensation7/16/2024
A pharma company used Signant Health's RTSM solution in a Phase 2 schizophrenia trial to ensure drug availability, maintain study balance, prevent duplicate allocations, and manage returns and destruction of unused drugs.
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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.
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Rescue Studies: Get Patient Recruitment Back On Track9/22/2025
What is a rescue study, and how can direct-to-patient digital recruitment be employed to rapidly boost recruitment and enrollment?
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Medable Beats Forecasted FPI Date While Raising eCOA Adherence In Japan2/7/2025
A top-10 global pharmaceutical company aimed to address eCOA adherence and patient enrollment challenges faced by clinical trial sites and participants in Japan. See how they accomplished it and more with this case study.
NEWSLETTER ARCHIVE
- 02.03.26 -- Common Issues And Trends In Clinical Research Vendor Qualification
- 02.02.26 -- Preeclampsia Research's Urgently Needed For Funding And Patient-Informed Trial Design
- 01.30.26 -- How Can Sites And Sponsors Continuously Monitor Clinical AI
- 01.29.26 -- Mock Inspection Advice From Former Regulatory Investigator
- 01.29.26 -- Turning Clinical Complexity Into Confident Decisions
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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![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.
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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?")
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?
FOCUS ON PATIENTS
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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.
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![Time management, deadline-GettyImages-2184911553]( "Confronting \"Time Toxicity\" In Global Oncology And Rare Disease Trials For Operational Excellence And Patient Retention")
Time is the only truly finite resource in a clinical trial. Consultant Leila Cupersmith discusses how sponsors can better design trials with a lower time burden to boost enrollment, retention, and overall operational excellence.
