Elisa Maggioli, Ph.D., explains that improving outcomes in HS may depend on moving beyond broad, symptom-based approaches toward more targeted, biologically informed strategies.
- Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials
- RWE Increasingly Supports Rare Disease Research As RCTs Alone Fall Short
- AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them
- Will AI And Agile Project Management Help Advance RBM?
- The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future
- Why Building Long-Term Value And Making Clinical Progress Are Inextricable
- What Sponsors Don't See: The Systems Behind Clinical Trial Delivery
GUEST COLUMNISTS
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The Next Chapter Of Obesity And Type 2 Diabetes Care: ADA 2026 Signals A More Personalized Future
The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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Why Building Long-Term Value And Making Clinical Progress Are Inextricable
Dicot Pharma CEO Elin Trampe discusses how clinical milestones, financing strategy, shareholder value, and partnering considerations must be tightly integrated in early development through late-stage planning.
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What Sponsors Don't See: The Systems Behind Clinical Trial Delivery
What do sponsors need from sites? Easy. How do they evaluate them? Not so easy (or accurate). In this column, Association Multisite Research Corporations (AMRC) Executive Director Jim Kremidas explains how sites and sponsors can make site evaluations better.
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What Really Happens At The Site When Sponsors Pull Back Mid-Trial
When sponsors slow or reduce operational spending due to financial pressure, strategic pivots, or internal restructuring, sites — and patients — suffer. Curo Research CCO Amy Bland explains how sponsors can better manage operational changes.
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A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI
Clinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.
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One Drug, Three Indications: How Small ClinOps Teams Manage Multi-Trial Execution
Having the same number of clinical programs as team members might sound crazy, but for Step Pharma, it has become one of their biggest strengths.
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Rare Disease Nonprofits: De-Risk Development With Orphan Drug Designation And Early Talks With The FDA
For nonprofit organizations, Orphan Drug Designation is the start of a disciplined, forward-looking regulatory strategy, but it's not the only factor in success. H. Greg Thomas, Ph.D., shares his advice for de-risking orphan drug development.
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The Compliance Problem With Excel Trackers And Other Computational Tools — And How AI Can Help
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.
CLINICAL TRIAL WHITE PAPERS
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Demanding More From AI Governance In Drug Safety
Embedding AI governance into your an AI-enabled safety system from the start empowers trust and streamlines the path toward success; it is merely the evolution of good data and risk governance.
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If Data Integrity Matters, Paper Is Not An Option3/5/2026
Ditch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.
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Eliminate Clinical Trial White Space With The Right AI Strategy10/9/2025
Learn how sponsors and CROs are using agentic AI to eliminate the unproductive time caused by manual, sequential processes and fragmented data systems.
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Understanding How To Build And Leverage A DSMB Statistical Plan7/23/2024
Get an overview of the essential components involved in providing independent statistical center support for a data safety monitoring board (DSMB), also known as a data monitoring committee (DMC).
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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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De-Risking Early-Stage Biotech: Turning Vision Into Venture Capital9/3/2025
For early-stage biotech companies, transforming a scientific breakthrough into an investable asset requires more than compelling data—it requires a clear product vision.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Breaking Down Operational And Financial Complexity In Clinical Trials12/8/2025
Consider how factors like hybrid visits, enrollment patterns, and variable procedure volumes shape both the cadence and magnitude of site payments, supplier activity, and patient-related expenses.
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How A Rare Disease Biotech Replaced Manual Processes With RTSM Software3/26/2026
Discover how a clinical-stage biotech automated its supply chain to protect patient enrollment and eliminate manual errors in a complex, multi-national genetic medicine trial.
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Early-Stage Development In Rare Pediatric Oncology4/11/2025
Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.
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Delivering Specialist Neurology Support4/17/2025
Explore a strategic approach to a Parkinson’s disease trial that leveraged a global infrastructure and multilingual workforce to provide seamless operational and clinical support.
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How We Used Intelligent Automation to Transform Vendor Selection7/2/2025
Discover how your small biotech can achieve faster timelines, improved cost control, and more strategic, transparent choices with a platform leveraging intelligent automation.
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Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration5/27/2026
Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.
NEWSLETTER ARCHIVE
- 06.30.26 -- Computer Software Assurance And Its Benefits
- 06.30.26 -- Better IDS Workflows Start Here
- 06.29.26 -- Breaking Barriers In Rare Disease Clinical Trials
- 06.26.26 -- How Is Remote Monitoring Transforming Compliance?
- 06.26.26 -- Support For Clinical Trial Patients, From Payments To Home Trial Support
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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AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?
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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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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.
FOCUS ON PATIENTS
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The American Diabetes Association 2026 conference showed where we are and where we're going with GLP-1 therapies.
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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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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.