Ernexa Therapeutics President & CEO Sanjeev Luther details having one the of 10 coveted spots in the Japan Entry Acceleration Program (JEAP) that supports cell therapy development and market entry in Japan.
- Why Clinical Data Standards Matter In An AI-Driven World
- How The Quiet Data Standards Revolution Is Impacting Drug Approval
- Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension
- What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And Use
- New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA
- The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It?
- How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running Smoothly
GUEST COLUMNISTS
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![Bacterial cells chains, Streptococcus pyogenes-GettyImages-2161636013]( "The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It?")
The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It?Strep A kills around 500,000 people each year, and a vaccine would change this and is within reach. Yet, no strep A vaccine is currently in Phase 3. 1Day Sooner's Josh Morrison explains why and shares how FDA could make Strep A vaccines a reality.
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![Healthcare, cooperation, teamwork-GettyImages-2191354117]( "How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running Smoothly")
How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running SmoothlyWhen acquiring another company, the acquiring sponsor must preserve operational continuity across active trials while integrating new assets, teams, technologies, vendors, and decision structures. Leila Cupersmith explains how.
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![Number 5-GettyImages-867537666]( "5 Signals Teams Should Track To Avoid Clinical Trial Execution Drift")
5 Signals Teams Should Track To Avoid Clinical Trial Execution DriftMany teams detect execution drift too late. To stay head, learn how to follow these five governance signals: documentation reliability, ownership clarity, dependency visibility, escalation discipline, and decision-ready review quality.
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![child getting vaccine-GettyImages-1678122790]( "Lessons In Pivoting From A Clinical Trial Launch In Uganda")
Lessons In Pivoting From A Clinical Trial Launch In UgandaGates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
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![Gastroenterology analysis, diagnosis, screening, medical research analytics-GettyImages-2261860563]( "DDW 2026 Signalled The Next Era Of Competitive Landscape In IBD")
DDW 2026 Signalled The Next Era Of Competitive Landscape In IBDAt the DDW 2026 meeting, the IBD landscape was portrayed as increasingly competitive and diversified, with emerging players and novel mechanisms challenging established standards of care.
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![Computer programmer at desk-GettyImages-973716000]( "What Is Computer Software Assurance, And What Are Its Benefits?")
What Is Computer Software Assurance, And What Are Its Benefits?Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.
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![GettyImages-1447898051]( "The FDA Is Rudderless And Clinical Trials Are Left Adrift")
The FDA Is Rudderless And Clinical Trials Are Left AdriftFormer commissioner Marty Makary, MD, left the FDA in May 2026. In his wake, he left an agency facing yet another wave of uncertainty. Denise N. Bronner attempts to navigate the latest change and offers advice for those seeking stability.
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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
Expanding Access To Cell Therapy Trials Beyond AMCs And Into The CommunityCEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
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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A Smartphone Based Biomarker For The Estimation Of Unipolar Depression Severity3/28/2025
The study investigates the potential of using smartphones and wearables to create objective biomarkers for mood disorders, specifically focusing on unipolar depression.
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The Real Cost In CNS Trials: Rater Drift And Site Readiness11/21/2025
Learn how to build resilience into CNS trial operations with evidence-based frameworks that prioritize human factors alongside digital tools.
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Futureproofing Post-Approval Compliance4/15/2026
In the post-approval stage, a synergistic operating model brings PV and regulatory functions under one umbrella: a single governance structure with shared decision cycles, templates, and evidence.
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The Next Era Of eCOA Is AI4/15/2026
Discover how AI is moving beyond the hype to streamline clinical study builds. Explore practical ways to automate protocol digitization and UAT scripts while preparing for future patient tools.
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Transforming Effective Patient Recruitment Within The Changing Health Care Landscape2/6/2026
Revolutionize patient enrollment by closing the "95% gap." Explore an approach that uses digital health and data-driven insights to engage diverse populations where they live.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Advancing Dose Escalation Strategies With Bayesian Modeling8/12/2025
A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.
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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.
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Removing Translation Bottlenecks With AI8/8/2025
See how an AI-enabled approach eliminated the manual, time-consuming translation bottlenecks that often delay clinical trial launches.
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How Pfizer Used Wearable DHTs To Reveal Meaningful Treatment Effects In Cancer Cachexia11/20/2024
Wearable digital health technologies (DHTs) played a crucial role in assessing patient-centric outcomes during pfizer's study into the benefits of using ponsegromab for treating cancer cachexia.
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Access And Retention In Metastatic Colorectal Cancer Trials4/21/2026
Making it easier for participants in metastatic colorectal cancer trials to reach specialized sites and stay on schedule with managed travel, lodging, and reimbursements
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Trial Rescue And Reconnaissance4/15/2026
Explore a strategic partnership that resulted in a rescue plan for a Phase III oncology trial that was facing high site decline rates.
NEWSLETTER ARCHIVE
- 06.15.26 -- Beyond Enrollment: The New Rules Of Trial Retention
- 06.13.26 -- May's Best: AI, Rare Disease Trials, eConsent, And More
- 06.12.26 -- 5 Signals Teams Should Track To Avoid Clinical Trial Execution Drift
- 06.11.26 -- Why Contracts Need To Catch Up To AI Appears In Clinical Trials
- 06.10.26 -- AI Amplifying Capabilities And Risks: The Legal Consequences Of AI In Clinical Research
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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![child getting vaccine-GettyImages-1678122790]( "Lessons In Pivoting From A Clinical Trial Launch In Uganda")
Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.
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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
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![Healthcare benefits enroll-GettyImages-882379348]( "Taking On Patient Recruitment From Another Angle — The Payer")
Medzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
FOCUS ON PATIENTS
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![Blue Print-GettyImages-172211936]( "A Blueprint For Addressing Underserved Patient Populations")
Does our current approach to clinical research truly serve the patients who face the greatest needs? Insmed Inc. CMO Martina Flammer, MD, MBA, explores how to better meet patient needs.
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![Disability, daily activities-GettyImages-2169336772]( "New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA")
NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.
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![Tidioute Health Care Center-GettyImages-1273786594]( "Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community")
CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access.
