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-2024666721-meeting-table-office-business-man-doctors]( "De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital")
De-Risking Early-Stage Biotech: Turning Vision Into Venture CapitalFor early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
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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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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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Advancing Alzheimer's Disease Therapies9/3/2025
By uniting scientific innovation with patient-focused execution, the next generation of alzheimer’s disease (AD) therapies has the potential to deliver a transformative impact on global health.
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Safeguarding Personal Data: Protecting PII8/4/2025
Learn about a secure, patient-centric platform that enables individuals to participate in clinical trials and registries while maintaining lifelong access to their data.
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Key AI Trial Insights From Regulators And Consultants4/4/2025
AI’s transformative impact promises more efficient, cost-effective, and successful clinical trials across the pharmaceutical landscape.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Streamlining Phase 1 Trials With The Mobile Vision Pod1/29/2025
A contract research organization formed a partnership to address significant challenges during a Phase 1 clinical trial for a corneal disease treatment through the use of a Mobile Vision Pod.
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Urgent Compliance Recovery Following Vendor Transition5/26/2026
Rapid local leadership, clear ownership of corrective actions, and governed oversight enabled time‑critical remediation of legacy safety gaps, restoring regulatory confidence and protecting market continuity under intense inspection pressure.
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Electronic Body Maps Drive Standardization Across Top-10 Pharma7/8/2024
Learn how a top-10 pharmaceutical client was able to "fundamentally transform the way they execute clinical trials" with the digitization and standardization of pain maps in a diabetic polyneuropathy trial.
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Targeted Indication Selection Using Adaptive Design8/12/2025
What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?
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Outgrowing Excel: Implementing RTSM In A Live Phase I Trial2/25/2026
Learn how a clinical-stage oncology biotech successfully transitioned a live Phase I trial from manual spreadsheets to RTSM without disrupting site momentum or patient enrollment.
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
NEWSLETTER ARCHIVE
- 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?"
- 06.09.26 -- Navigating Risk And Capital Scarcity With AI
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.
