Benchmarking is widely used and highly valued, yet trust in it is limited. The League Benchmarking Working Group has set out to standardize how site metrics are defined, contextualized, and applied.
- How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running Smoothly
- 3 Views From Inside FDA's RTCT Pilot
- 5 Signals Teams Should Track To Avoid Clinical Trial Execution Drift
- Lessons In Pivoting From A Clinical Trial Launch In Uganda
- DDW 2026 Signalled The Next Era Of Competitive Landscape In IBD
- The Patient Recruitment Debate Nobody's Having
- What Is Computer Software Assurance, And What Are Its Benefits?
GUEST COLUMNISTS
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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.
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![GLP-1 agonist injector pen, medical measuring tape-GettyImages-2226642622]( "Why Tolerability Will Drive The Next Wave Of Obesity Treatments")
Why Tolerability Will Drive The Next Wave Of Obesity TreatmentsFor the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.
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![Genetic engineering, GMO and Gene manipulation-GettyImages-1344879684]( "Why Cell And Gene Therapy Has Not Reached More Patients — And Why Clinical Operations Is The Bridge")
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![Female doctor examining patient-GettyImages-2217109316]( "Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid Tumors")
Safety Is The Mantra In Kivu Bioscience's ADC Trials For Solid TumorsKivu Bioscience CEO Mohit Trikha, Ph.D., contends that safer ADCs enable higher effective dosing and could elicit a better response in solid tumors. In this Q&A, he also discusses how parallel trial execution, global site strategy, and stakeholder collaboration support rapid, data-driven development.
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![Healthcare benefits enroll-GettyImages-882379348]( "Taking On Patient Recruitment From Another Angle — The Payer")
Taking On Patient Recruitment From Another Angle — The PayerMedzown CEO Jennifer Carter, MD, discusses the challenge of patient recruitment and how coalescing around clinical care data might be a better “in” for recruitment.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1421515036-genetic-DNA-helix-gene]( "Reimagining Medical Monitoring In Clinical Research")
Reimagining Medical Monitoring In Clinical ResearchClinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
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Disclosure Management System: Build Or Buy?6/19/2025
Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
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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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The True ROI Of Decentralized Clinical Trials11/13/2025
Gain a greater understanding of how the right DCT solution, or combination of solutions, coupled with clear metrics and expert guidance on execution, can demonstrate tangible, quantitative ROI in clinical trials.
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Addressing Trial Design Hurdles Across Alzheimer’s Disease Stages12/10/2025
Explore how endpoint selection, rater training, and the strategic implementation of eCOA can help address the unique scientific, operational, and human considerations at each stage of AD.
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The Strategic Advantage Of eCOA And IRT8/11/2025
The future lies in unified, interoperable eCOA–IRT solutions that streamline operations, improve data integrity, and enhance patient and site experience.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Rescuing Data Integrity: A Swift Transition And Quality Transformation11/14/2025
Uncover how this collaboration supported timely progress toward key study milestones, enabling smoother execution and more dependable output across data management and statistical activities.
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Participant Support In Oncology Trials With Cachexia-Related Burden4/21/2026
Coordinated travel, reimbursements, and visit logistics for oncology participants experiencing fatigue, weight loss, and reduced mobility, helping reduce dropouts and keep people engaged.
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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 Approval Pathway For Phase III Ovarian Cancer Trial8/29/2025
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
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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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How To Seamlessly Integrate NetSuite With Power BI8/12/2024
Unlock the power of your NetSuite data with seamless integration to Power BI. Learn how to automate data refresh, gain real-time insights, and make informed business decisions.
NEWSLETTER ARCHIVE
- 06.09.26 -- Navigating Risk And Capital Scarcity With AI
- 06.08.26 -- Personal And Financial Support For Clinical Trial Participants
- 06.05.26 -- FDA's Draft Guidance On Bayesian Methods
- 06.05.26 -- Distributing, Exchanging, And Managing Study Documents Electronically
- 06.04.26 -- Contracting For AI In Clinical Trials
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.
-
![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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![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.
-
![GLP-1 agonist injector pen, medical measuring tape-GettyImages-2226642622]( "Why Tolerability Will Drive The Next Wave Of Obesity Treatments")
For the next generation of obesity medicines, enhancing how patients experience therapy will inform discovery and development efforts and may ultimately determine long-term success.
