Learn the key considerations to anticipate and mitigate risks that CTAs and diligence in the clinical trial space present during mergers and acquisitions (M&As).
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
- Behavior Modeling Can Help Sponsors Better Understand Sites And Patients
- How The U.S. Can Beat China In Biotech
- Funding Diversity Where It Starts — At the Site
- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads
- How AI Is Transforming Patient Stratification
- The Rise Of Specialist CROs In Clinical Outsourcing
GUEST COLUMNISTS
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![colorful arrows pointing up-GettyImages-2152056193]( "The Rise Of Specialist CROs In Clinical Outsourcing")
The Rise Of Specialist CROs In Clinical OutsourcingUnderstand the trends behind the growing specialist CRO sector.
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![Online documentation database, AI, artificial intelligence, dms, GettyImages-2078225287]( "How AI Is Rewriting The Future Of TMF And Clinical Quality")
How AI Is Rewriting The Future Of TMF And Clinical QualityDiscover how AI is transforming the TMF from a reactive repository into a proactive, intelligent co-pilot for clinical trials.
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![beroe_raredisease3-gettyimages-1629549075]( "Trends In Rare Disease Trials: Recommendations")
Trends In Rare Disease Trials: RecommendationsIn the third article of this series, analyst reveal their top 6 recommendations for designing selection criteria and selecting solution options to optimize rare disease research outcomes.
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![Senior man at clinic reception desk-GettyImages-2174582061]( "The Hidden Power Of Specialized Community Research Sites In Accelerating Clinical Trials")
The Hidden Power Of Specialized Community Research Sites In Accelerating Clinical TrialsTyler Research Institute founder G. Aaron DuVall explores how community sites can offer access to diverse patient populations and build processes tailored for chronic disease care to accelerate timelines and improve outcomes.
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![Career Path-GettyImages-2239749438]( "Regulatory Pathways — With Real-Life Examples — For Successful CGT Clinical Trials")
Regulatory Pathways — With Real-Life Examples — For Successful CGT Clinical TrialsDiscover the most effective regulatory pathways used to support CGT development, including two real-life examples.
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![vaccination at medical clinic-GettyImages-1364924483]( "Continuous Evidence Generation — Including RWE — Remains Critical To Vaccine Development")
Continuous Evidence Generation — Including RWE — Remains Critical To Vaccine DevelopmentPresident of Takeda's Global Vaccine Business Unit Derek Wallace discusses the importance of continuous, real-world data collection in the context of vaccine development in low- and middle-income countries.
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![sunlit brain puzzle-GettyImages-2187021354]( "How Redefining The Diagnostic Odyssey Can Lead To Better Patient Outcomes")
How Redefining The Diagnostic Odyssey Can Lead To Better Patient OutcomesPatient advocate Wendy Cogan calls for improved diagnostic pathways as a means to better clinical trial recruitment and design while telling the journey of her late husband's journey to a corticobasal degeneration(CBD)-frontal behavioral-spatial syndrome (FBS) diagnosis.
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![Target business strategy and success motivation symbol digital-GettyImages-2190546471]( "Careful Outsourcing Proves Key To Targeted Protein Degradation Drug Development")
Careful Outsourcing Proves Key To Targeted Protein Degradation Drug DevelopmentDiscover how partnerships — especially with capable CROs — as well as resilient supply chains, digital enablement, regulatory foresight, and specialized talent impact the success of targeted protein degradation therapies.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1509265795-blocks-FDA-pills-pharma-clinical]( "Unpacking FDA's Final Rule To Regulate LDTs")
Unpacking FDA's Final Rule To Regulate LDTsDiscover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.
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Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress7/15/2025
Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.
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New Duke Research Shows Participants Prefer Enhanced eConsent10/7/2024
It’s apparent to those who have used it that the “e” in eConsent could stand for much more than 'electronic'. Duke’s new research shows why participants prefer an eConsent experience bolstered with videos, media, questions, and more.
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Global Trial Disclosure Landscape Grows Increasingly Complex4/15/2025
The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.
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Overcoming Issues Of Non-Enrolling Sites In Clinical Trials1/14/2025
Explore the challenges of non-enrolling sites in clinical trials, focusing on the benefits of leveraging artificial intelligence (AI) and machine learning (ML) in addressing those issues.
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Digital Endpoint Resource Guide: Neuromuscular Disorders3/15/2024
Find out how sensor-based digital health technologies (DHTs) offer direct, objective daily life assessments, accelerating NMD drug development.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How Medidata Link Is Supporting Moderna's Clinical Trial Real-World Data Linkage Initiatives6/5/2024
Discover how Medidata Link empowers Moderna's clinical trial RWD linkage initiatives, enhancing insights into treatment outcomes while minimizing administrative burdens.
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Unlocking Recruitment Potential In Trial-Naïve Sites4/17/2025
Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
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Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot8/19/2024
Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.
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Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice10/30/2024
See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.
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Optimizing Recruitment For Urgently Needed Vaccine5/15/2024
Uncover how Citeline Connect helped a late-stage biotech sponsor expedite enrollment of a diverse population of eligible patients impacted by monkeypox for a large Phase 1 and Phase 2 trial of a next-generation vaccine.
NEWSLETTER ARCHIVE
- 11.04.25 -- Clinical Trials At A Crossroads
- 11.03.25 -- A New Site With An Old Truth: Access Is Everything
- 11.03.25 -- Rethinking Clinical Vendor Selection: From Spreadsheets To AI-Based Analytics
- 10.31.25 -- Mastering The Monitoring Visit: Tips For Site Success
- 10.31.25 -- AI-Assisted Reconciliation, eCOA Automation, And TMF Excellence
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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![Human mind, experience diversity, personality characteristics-GettyImages-2203518410]( "Behavior Modeling Can Help Sponsors Better Understand Sites And Patients")
Learn how behavioral modeling can identify patients at risk of dropout and sites that may need additional support, so you can build a more resilient research network.
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![Businesswoman walking in crowd-GettyImages-2208884463]( "How AI Is Transforming Patient Stratification")
Discover how AI tools can help stratify or group patients into subtypes that respond differently to treatment.
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![vaccination at medical clinic-GettyImages-1364924483]( "Continuous Evidence Generation — Including RWE — Remains Critical To Vaccine Development")
President of Takeda's Global Vaccine Business Unit Derek Wallace discusses the importance of continuous, real-world data collection in the context of vaccine development in low- and middle-income countries.
FOCUS ON PATIENTS
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![Human mind, experience diversity, personality characteristics-GettyImages-2203518410]( "Behavior Modeling Can Help Sponsors Better Understand Sites And Patients")
Learn how behavioral modeling can identify patients at risk of dropout and sites that may need additional support, so you can build a more resilient research network.
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![sunlit brain puzzle-GettyImages-2187021354]( "How Redefining The Diagnostic Odyssey Can Lead To Better Patient Outcomes")
Patient advocate Wendy Cogan calls for improved diagnostic pathways as a means to better clinical trial recruitment and design while telling the journey of her late husband's journey to a corticobasal degeneration(CBD)-frontal behavioral-spatial syndrome (FBS) diagnosis.
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![Polarized Politics, American Culture Crisis-GettyImages-1472585580]( "How Government Shutdowns Set Back Clinical Trials")
When the federal government shuts down, clinical research suffers. Empactful Ventures' Denise N. Bronner, Ph.D., explains the wide-reaching ramifications.
