Medical director and clinical lead Jason T. Lerner, MD discusses Biohaven's patient-centric approach to its pediatric epilepsy clinical trials, from reducing visit frequency to offering virtual visits and more.
- What Does It Mean To Be "Underserved"?
- Why Hire An Interim Chief Medical Officer?
- 7 Most Talked About Factors To Transform Clinical Trials
- Using Critical To Quality (CtQ) Factors To Identify The Critical Data For RBQM
- How AI Will Transform Health Equity In Clinical Trials In 2025
- AI Won't Save Us: Why We Must Save Ourselves
- What Future Laboratory Manuals Should Look Like
GUEST COLUMNISTS
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![Derk-Edit-Headshot]( "AI Won't Save Us: Why We Must Save Ourselves")
AI Won't Save Us: Why We Must Save OurselvesWe need to bring automation, technology, and AI to the true bottlenecks of drug development — not just the early discovery phases or broader topics such as site selection but the nuts and bolts of clinical trial execution. AI can help reduce the day-to-day burden on clinical trial sites, automate repetitive tasks, and minimize the manual work that adds no value but leads to burnout.
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![Healthcare worker drawing blood from patient-GettyImages-2158952149]( "What Future Laboratory Manuals Should Look Like")
What Future Laboratory Manuals Should Look LikeIn the final article of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair imagines what the perfect lab manual might look like — and how to make it a reality.
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![innovation, medical research, diagnosis, headache-GettyImages-2163767434]( "How Laboratory Manuals Fail Sites And Sponsors")
How Laboratory Manuals Fail Sites And SponsorsIn part one of this series, FlexPoint Bio Founder and CEO Elena Sinclair describes the hazards of poorly designed (and followed) clinical trial lab manuals.
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![Blood samples in laboratory-GettyImages-1773074083]( "Lab Manual Gaps: Sabotaging Data One Sample At A Time")
Lab Manual Gaps: Sabotaging Data One Sample At A TimeIn part two of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair discusses the criticality of sample and process quality.
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![freishtat_fig1Bucket]( "Feels Like Home: Designing Sites For Patient Comfort")
Feels Like Home: Designing Sites For Patient ComfortCold, stark, and purely functional, healthcare settings have long lacked the comfort and familiarity of home — until now. Uncommon Cures has used the science of hope to inspire its cozy, comfortable new trial site.
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![Home healthcare options-GettyImages-1366650120]( "Sick, Well, Or Somewhere In Between: Understanding The Patient Decision To Enroll In A Clinical Trial")
Sick, Well, Or Somewhere In Between: Understanding The Patient Decision To Enroll In A Clinical TrialParticipating in clinical research involves profoundly personal and practical psychosocial considerations. Clinical Behavioral Healthcare Specialist Emily Epstein explains.
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![Stethoscope with national flag brazil-GettyImages-537716595]( "BeiGene Details Its Approach To Expanding Oncology Trials Into Brazil")
BeiGene Details Its Approach To Expanding Oncology Trials Into BrazilIn this second article, BeiGene's Lígia Campos details its journey to setting roots in Brazil, sharing its beginnings there and highlighting its approach to study start-up and patient recruitment and enrollment.
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![National Healthcare system brazil-GettyImages-536190941]( "BeiGene Explains The Landscape Of Oncology Trials In Brazil")
BeiGene Explains The Landscape Of Oncology Trials In BrazilIn part one of this two-part series, BeiGene's Brazil and LATAM clinical operations head Lígia Campos details Brazil's cancer treatment landscape and the benefits of expanding oncology trials there.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1394446062 regulatory]( "Outsourcing Lifecycle Maintenance To A FSP Regulatory Affairs Partner")
Outsourcing Lifecycle Maintenance To A FSP Regulatory Affairs PartnerExplore how an FSP partnership can streamline your regulatory processes, ensuring sustained compliance and efficiency while bringing new drugs or devices to market.
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Bladder Cancer Global Clinical Trial Landscape (2024)11/12/2024
Bladder cancer is the ninth most common cancer in the world and thirteenth in mortality. This report provides a detailed overview of the clinical trial landscape for bladder cancer.
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What 4 Things Do All eCOA Studies Need To Succeed?8/8/2023
Learn what else, in addition to good technology, study teams need for eCOA studies to succeed.
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Immune Checkpoint Inhibitors Global Clinical Trials Landscape (2023)11/27/2023
Dive into the forefront of immune checkpoint inhibitors clinical trials with an exploration of the latest trends and key findings.
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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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Robust Models For Supporting PV And Medical Information Activity8/15/2023
Learn how outsourcing local pharmacovigilance and medical information activities to an established safety organization can provide high-quality expertise and technology that meets demand.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Unraveling Duchenne Muscular Dystrophy6/27/2023
Rare disease studies in remote locations often face logistical challenges to completion. Explore the effective impact personalized patient support services can have on clinical trial success.
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Pursuing Breakthrough Therapies For Rare Metabolic Diseases2/14/2024
Explore how a comprehensive clinical trial team expertly coordinated the dosing administration and data review for gene therapy, ensuring meticulous management and streamlined processes.
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Our Unified Platform Serves As eSource For COVID Treatment Trial6/17/2024
Signant Biotech optimized technology for an emerging biopharmaceutical's Phase 2 COVID treatment trial in critically ill patients, minimizing paper data risks and streamlining consent and data management across multiple sites and solutions.
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The Impact Of Automation In The Monitoring And Reporting Process5/21/2024
As clinical trial costs rise and ROIs decline, research teams are turning to automation to streamline monitoring and reporting processes without compromising data quality or regulatory compliance.
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Biostatistics And Programming — More Than Just Clinical Trials5/28/2024
See how our biostatisticians and programmers successfully ingested, cleaned, and analyzed the data, ultimately providing a small biotech company with several interesting and actionable measures.
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Professional Services Expedite Hospital's Study Process11/17/2023
Explore the details of a transformative partnership where a children's hospital was able to overcome coverage analysis and budget negotiation issues despite a significant staff turnover.
NEWSLETTER ARCHIVE
- 01.20.25 -- Here's A Template — And Tips — For Assessing And Improving Patient Centricity
- 01.17.25 -- AI's Potential Must Reconcile With R&D And Regulatory Bottlenecks
- 01.16.25 -- What Does The Data Science Industry Have To Say About The ICH M11 Guideline?
- 01.15.25 -- STREAM by Life Science Connect: Video for the Life Science Professional
- 01.15.25 -- We Are All Project Managers, But We Need Help
CONTENT COLLECTIONS
2024 CRO LEADERSHIP AWARDS
See who the winners are of the 2024 CRO Leadership Awards.
FOCUS ON PATIENTS
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![Mental Health, Stroke, Epilepsy and alzheimer awareness, seizure disorder-GettyImages-1306217369]( "Biohaven Refines Epilepsy Trial Design With Patient-Centric Focus")
Medical director and clinical lead Jason T. Lerner, MD discusses Biohaven's patient-centric approach to its pediatric epilepsy clinical trials, from reducing visit frequency to offering virtual visits and more.
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![Adult woman sits in waiting room-GettyImages-1372189785]( "What Does It Mean To Be \"Underserved\"?")
Learn what makes someone "underserved," understand the importance of that person's participation in research, learn about the barriers to them doing so, and discover ways to improve their inclusion.
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![number 7 speech bubble-GettyImages-1244658794]( "7 Most Talked About Factors To Transform Clinical Trials")
Ivanna Rosendal, global head of digitalization at Ascendis Pharma, shares the seven things guests on her podcast "Transformation in Trials" think will transform clinical trials.
RECRUITMENT AND DIVERSITY
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![Adult woman sits in waiting room-GettyImages-1372189785]( "What Does It Mean To Be \"Underserved\"?")
Learn what makes someone "underserved," understand the importance of that person's participation in research, learn about the barriers to them doing so, and discover ways to improve their inclusion.
-
![Home healthcare options-GettyImages-1366650120]( "Sick, Well, Or Somewhere In Between: Understanding The Patient Decision To Enroll In A Clinical Trial")
Participating in clinical research involves profoundly personal and practical psychosocial considerations. Clinical Behavioral Healthcare Specialist Emily Epstein explains.
-
![freishtat_fig1Bucket]( "Feels Like Home: Designing Sites For Patient Comfort")
Cold, stark, and purely functional, healthcare settings have long lacked the comfort and familiarity of home — until now. Uncommon Cures has used the science of hope to inspire its cozy, comfortable new trial site.
