Barnes & Thornburg partner Seth Mailhot provides a primer on risk disclosure and how sponsor companies can prepare for and mitigate issues that might arise.
- What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman
- Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic
- PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients
- Wanted: More Women For Clinical Trials
- FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To Know
- How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment
- Patient-Powered Drug Trials Are Getting The FDA Greenlight
GUEST COLUMNISTS
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![Affordable care act-GettyImages-1148533483]( "How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment")
How The ACA Subsidy Lapse Could Hurt Clinical Trial EnrollmentThe relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.
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![Traffic light over urban intersection-GettyImages-1168877430]( "Patient-Powered Drug Trials Are Getting The FDA Greenlight")
Patient-Powered Drug Trials Are Getting The FDA GreenlightPatient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.
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![privacy, data breach, cybersecurity-GettyImages-2214686070]( "When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down")
When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks DownRegulators want one thing during inspections — to see how the data flows, says Just In Time GCP's Donna Dorozinsky. Here, she explores the importance of data oversight and where sponsors sometimes go wrong.
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![innovation, eco tech, ideas for sustainability, clean energy, future green solutions-GettyImages-2237001907]( "How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026")
How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026Deep learning is reshaping clinical trial design, execution, and analysis. Learn how to deploy it safely, measurably, and at scale with help from life sciences consultant and MIT industry advisor Partha Anbil.
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![World AIDS Day-GettyImages-1467238981]( "The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development")
The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug DevelopmentDiscover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.
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![network connection-GettyImages-920720422]( "Avoid Clinical Alignment Breakdowns With \"Lateral Agility\"")
Avoid Clinical Alignment Breakdowns With "Lateral Agility"Internal misalignment can stall the clinical timeline, erode the window of patent protection, and jeopardize funding. Learn why leadership can no longer be and instead must exhibit "lateral agility" across the enterprise.
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![business, teamwork,collaboration-GettyImages-922937404]( "Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes")
Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything ChangesThe outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.
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![Risk protection, business and life-GettyImages-1872872331]( "The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board")
The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On BoardTufts CSDD’s Beth Harper shares findings from the org's latest Impact Report and discusses how companies might better define risk, measure success, and understand central monitoring.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1509265795-blocks-FDA-pills-pharma-clinical]( "Unpacking FDA's Final Rule To Regulate LDTs")
Unpacking FDA's Final Rule To Regulate LDTsDiscover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.
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Challenges And New Approaches To Developing Clinical Evidence For Medical Devices9/12/2024
Learn about the challenges and new approaches to developing clinical evidence for medical devices, including decentralized trials, adaptive studies, in silico trials, and real-world evidence.
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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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Empower Your Trial With Data And Evidence1/14/2026
Fuel your clinical development and decision-making with insights from fit-for-purpose data and evidence.
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Navigating The FDA's Drug Supply Chain Security Act3/14/2025
Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.
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Continuous Cough Monitoring: Addressing Placebo Effects And Data Gaps7/7/2025
Modernizing symptom monitoring is essential to improving clinical trial quality, and these tools deliver richer, more accurate data that can help close information gaps.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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End-To-End Inventory Control Supports Biotech's Expanding Portfolio2/19/2026
Many organizations struggle with siloed operations, but this modern GxP inventory solution solves these challenges by providing a centralized, cloud-based platform for end-to-end visibility.
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Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration6/26/2025
A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.
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Preparing The Next Generation Of Clinical Research Professionals9/4/2025
Explore the live EDC platform that enabled Durham Tech to create a model for future-forward, hands-on education in clinical research.
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Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer11/17/2025
Choose a development partner who can navigate global execution, ADC-specific challenges, and Project Optimus requirements so your first-in-human study is designed and positioned for success.
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Optimizing Chronic Cough Phase 3 Trials With Point-Of-Need Eye Assessments1/15/2025
Collaboration was key for Company W to overcome challenges with an FDA-mandated ocular substudy, including limited resources for ocular assessments and logistical difficulties
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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.
NEWSLETTER ARCHIVE
- 03.19.26 -- The Cost Of Transactional Thinking In Clinical Research
- 03.19.26 -- Ditch Paper Now: eCOA Innovations For Smarter Trials
- 03.18.26 -- Informed Consent Isn't Broken — But It's Barely Working
- 03.18.26 -- STREAM Edition: Health Equity Isn't A Buzzword — It's A Business Imperative
- 03.17.26 -- AI In Clinical Trials What's New And What's Hype
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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![Gold key hung in the middle-GettyImages-1310224740]( "The Art Of Finding And Keeping The Right KOL")
Learn from Incyclix CEO Patrick Roberts how the company identifies its KOLs, tailors engagement to their expertise, measures collaboration success, and sustains successful long-term partnerships.
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![Doctor and patient in nursing home-GettyImages-1345138968]( "PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients")
Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
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![Affordable care act-GettyImages-1148533483]( "How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment")
The relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.
FOCUS ON PATIENTS
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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman")
Origami Therapeutics CEO Beth Hoffman shares how the company took both a measured and a gut-feeling approach to finding the right partner to supports its development of protein degraders for neurodegenerative diseases.
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![Doctor and patient in nursing home-GettyImages-1345138968]( "PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients")
Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
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![Traffic light over urban intersection-GettyImages-1168877430]( "Patient-Powered Drug Trials Are Getting The FDA Greenlight")
Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.
