Pediatric cancer advocates Brian Burkhardt and Andy Shepperd believe clinical research still confuses retention with relationships. Their lessons on trust, community, and patient support offer valuable insights for clinical operations teams across every therapeutic area.
- 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
- 3 Views From Inside FDA's RTCT Pilot
GUEST COLUMNISTS
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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.
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![ispor]( "What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026")
What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026On the heels of ISPOR 2026, discover what relevancy HEOR has in the world of clinical operations.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1316574146-computer-monitoring-office-hands-keyboard]( "The Next Era Of eCOA Is AI")
The Next Era Of eCOA Is AIDiscover 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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Real-Time Clinical Data Insights Delivered By Automation And AI2/26/2026
Automated data flows and human‑guided AI enable faster, more reliable oversight into clinical trials. Learn how real‑time insights and unified monitoring support quality, efficiency, and readiness.
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Antibody-Drug Conjugates: 'Magic Bullets' Become Reality2/19/2025
Cancer therapy has evolved from potent chemotherapy to targeted biological therapy, including antibody-drug conjugates (ADCs). Learn more about ADCs’ makeup, mechanisms, and the development landscape.
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Practical Strategies For Diverse Trial Recruitment11/11/2024
The clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
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Digital Endpoint Resource Guide: Obesity And Related Metabolic Disorders8/15/2024
Explore how digital health technologies can enhance obesity treatment by providing critical insights beyond weight loss.
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The Importance Of A Maturity Model For Clinical Trial Transparency10/23/2024
A comprehensive maturity model for clinical trial disclosure and transparency offers companies a strategic tool to assess and enhance their practices in an increasingly complex regulatory environment.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission1/27/2026
Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.
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Transforming European Case Intake Operations5/26/2026
Centralized intake and semi‑automation brought clarity and control to European safety reporting, improving oversight, data quality, and compliance across multiple partners and countries.
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Accelerating Clinical Data Review With Traceable Workflows12/3/2025
Clinical data review needs centralized access and traceable workflows. Leveraging AI-automation and real-time collaboration drives faster, better-informed decisions and reduced compliance risk.
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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.
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Recruitment To Screening: Bridging The Gap12/5/2025
Explore how providing tracked transportation for patients can streamline recruitment, improve site conversion rates, and deliver measurable ROI for clinical trials.
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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.
NEWSLETTER ARCHIVE
- 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
- 06.10.26 -- STREAM Edition: Is Real-World Data "Messy?"
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.
-
![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.
