Everyday computational tools such as Excel are simple and easy to use, but they carry risk. Learn how these tools might not adhere to 21 CFR Part 11, and discover how AI can help keep them compliant.
- What ClinOps Gets Wrong About Pediatric Trials
- A Blueprint For Addressing Underserved Patient Populations
- 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
GUEST COLUMNISTS
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![business people working together-GettyImages-500224928]( "What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And Use")
What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And UseBenchmarking 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.
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![Disability, daily activities-GettyImages-2169336772]( "New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA")
New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDANervGen 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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![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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1025834378-manufacturing-excipient-drug-pharma]( "Navigating Adverse Immunostimulation: A Practical Guide For Clinical Researchers")
Navigating Adverse Immunostimulation: A Practical Guide For Clinical ResearchersExplore a systematic approach to evaluate adverse immunostimulation (AIS) in drug development through standardized biomarker sampling and tailored management strategies.
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The Patient Experience Paradox: eCOA Strategy Overhaul3/25/2026
European regulatory shifts now require the systematic integration of patient data. Success depends on aligning clinical and market access strategies through rigorous evidence generation.
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Navigating The Challenges Of Large, International Phase III Breast Cancer Trials5/27/2026
In the competitive landscape of breast cancer research, aligning biomarker testing, regulatory pathways, and regional operations from day one creates a path to faster enrollment and stronger outcomes.
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Participant Payments: Navigating Modern Studies12/18/2024
To address the challenges of disbursing clinical trial participant payments globally, sponsors need region-specific payment solutions that navigate local laws and banking systems.
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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.
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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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Helping To Power The WHO Solidarity Trial Against COVID-193/21/2025
To overcome the unprecedented challenges of large-scale global clinical trials, adopting data capture solutions is essential for ensuring the success of critical research initiatives.
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How Cara Therapeutics Increased Compliance And Reduced Study Team Burden7/31/2025
Delve into the partnership that helped Cara Therapeutics achieve a significant milestone in their clinical research efforts to transform the lives of chronic pruritus patients.
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Paperless Online Remote Source Document Verification2/2/2026
Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.
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Delivering Complex Oncology Trials At Scale5/19/2026
Parexel delivered two complex, global Phase III prostate cancer trials by aligning site selection, logistics, imaging workflows, and RAM regulatory expertise—achieving faster enrollment and on‑time execution.
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Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments2/3/2025
A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
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Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments1/29/2025
During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.
NEWSLETTER ARCHIVE
- 06.16.26 -- Turning Clinical Data Into Operational Advantage
- 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
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.
