The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.
- Non-Invasive Brain-Computer Interface Trial Balances Regulatory Requirements With Patient Needs
- Turning Site-Centric From Slogan To Reality
- Heading For An M&A? Understand The Risks And Mitigation Strategies For Clinical Trial Agreements
- Sites Are 3X Likely To Die In The First Year Than New Businesses
- Sponsors Collect Too Much "Non-Essential" Data, Say Tufts And TransCelerate
- Two Former FDA Chiefs, Two Very Different Warnings
- Global Implications Of Zero Tariffs On Indian Pharma Exports To China
GUEST COLUMNISTS
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![India and us flags-GettyImages-1089423548]( "Global Implications Of Zero Tariffs On Indian Pharma Exports To China")
Global Implications Of Zero Tariffs On Indian Pharma Exports To ChinaDiscover the worldwide impacts of China’s zero-tariff policy on Indian pharmaceutical drugs.
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![community nurse with three teens-GettyImages-1442937688]( "Participant Recruitment In LMIC Clinical Trials")
Participant Recruitment In LMIC Clinical TrialsDue to the high burden of infectious diseases in low- and middle-income countries (LMICs), there is greater urgency for vaccine trials. Participant recruitment entails significant work with communities.
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![Human mind, experience diversity, personality characteristics-GettyImages-2203518410]( "Behavior Modeling Can Help Sponsors Better Understand Sites And Patients")
Behavior Modeling Can Help Sponsors Better Understand Sites And PatientsLearn 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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![China and united states flag-GettyImages-1089423344]( "How The U.S. Can Beat China In Biotech")
How The U.S. Can Beat China In BiotechLumen Bioscience's Brian Finrow breaks down China's biotech playbook and explores ways the U.S. can adapt it for its own continued success.
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![Businesswoman walking in crowd-GettyImages-2208884463]( "How AI Is Transforming Patient Stratification")
How AI Is Transforming Patient StratificationDiscover how AI tools can help stratify or group patients into subtypes that respond differently to treatment.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1483611679-computer-cloud-digital-files-hands-keyboard]( "How Digitized Protocols Are Accelerating Clinical Research")
How Digitized Protocols Are Accelerating Clinical ResearchDigitized protocols, enhanced by artificial intelligence (AI), are transforming clinical trial operations by accelerating document generation, system integration, and trial optimization.
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What Clinical Trial Decision Makers Are Prioritizing In 20255/7/2025
In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.
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Understanding Safety Tactics, Regulatory Considerations In JAPAC1/12/2024
As the Japan and Asia-Pacific region continues to grow as a hot spot for clinical research, pharma companies will need expert understanding of regulatory nuances to ensure compliance.
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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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Diffuse Large B-Cell Lymphoma- Global Clinical Trial Landscape10/15/2024
Explore the latest advancements in diffuse large B-cell lymphoma research, innovative therapies, and personalized care strategies shaping the future of treatment.
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Innovative FSP Solutions For Biopharma Growth And Transition3/24/2025
To optimize clinical development, the pharmaceutical industry is increasingly adopting innovative outsourcing strategies with CROs.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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A Community-Focused Approach To Metabolic Disease Trials8/28/2024
Learn how innovative strategies like free health exams, community engagement, and a comprehensive patient database helped this project achieve rapid enrollment with a high level of patient diversity.
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Patient Engagement: Early Cancer Detection Blood Draw4/17/2024
Discover how we aided a pharmaceutical company in enrolling participants for a Phase III trial, DETECT-ASCEND 2, focused on Plasma-Based CancerSEEK Testing for early cancer detection.
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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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Data Key In Addressing Patient Recruitment Challenges6/19/2025
Explore how a Phase II trial for extensive-stage and previously treated small cell lung cancer overcame recruitment challenges with a data-driven solution designed to surface protocol-matched patients.
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Enhancing ER Patient Recruitment6/26/2024
Scout's custom information delivery mechanism for clear, accessible patient education facilitated trial enrollment in a high-pressure emergency room setting.
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Expanding Diabetes-Related Eye Health Equity1/29/2025
20/20 Onsite, American Diabetes Association and Genentech collaborated on an event to provide immediate diagnostic services, including retinal imaging and visual acuity assessments, directly on-site.
NEWSLETTER ARCHIVE
- 11.14.25 -- Why CRA Proficiency Needs A Boost From Better Assessment And Training
- 11.14.25 -- Less Workload, More Patient Time: Elevating The Site Voice
- 11.13.25 -- The Rise Of Specialist CROs In Clinical Outsourcing
- 11.13.25 -- From Chaos To Control: Modernizing Data And Mastering Clinical Trials
- 11.12.25 -- Ask An Expert Before Shredding Your Mobile Device CAPEX
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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![People getting covid vaccine GettyImages-1337773066]( "New Initiative Helps Researchers Enroll Healthy Volunteers In High Impact Trials")
1Day Sooner’s Director of Clinical Trials Circe MacDonald talks about their new Cooperative Patient Organization, the recruitment gaps it hopes to fill, and the importance of incorporating participant input.
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![metaverse technology-GettyImages-1372364665]( "Non-Invasive Brain-Computer Interface Trial Balances Regulatory Requirements With Patient Needs")
Cognixion CTO Chris Ullrich introduces the Axon-R Nucleus bio-sensing hub and discusses its feasibility trial, highlighting the importance of patient input, caregiver quality of life, and regulatory support.
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![community nurse with three teens-GettyImages-1442937688]( "Participant Recruitment In LMIC Clinical Trials")
Due to the high burden of infectious diseases in low- and middle-income countries (LMICs), there is greater urgency for vaccine trials. Participant recruitment entails significant work with communities.
FOCUS ON PATIENTS
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![People getting covid vaccine GettyImages-1337773066]( "New Initiative Helps Researchers Enroll Healthy Volunteers In High Impact Trials")
1Day Sooner’s Director of Clinical Trials Circe MacDonald talks about their new Cooperative Patient Organization, the recruitment gaps it hopes to fill, and the importance of incorporating participant input.
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![metaverse technology-GettyImages-1372364665]( "Non-Invasive Brain-Computer Interface Trial Balances Regulatory Requirements With Patient Needs")
Cognixion CTO Chris Ullrich introduces the Axon-R Nucleus bio-sensing hub and discusses its feasibility trial, highlighting the importance of patient input, caregiver quality of life, and regulatory support.
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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.
