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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![Home Diabetes Treatment iStock-1127801655]( "Bringing Clinical Trials To Everyone's Backyard")
Bringing Clinical Trials To Everyone's BackyardLearn how bringing clinical trials to any community around the world is not only possible but also increases patient access and reach and improves recruitment and retention.
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Challenges, Opportunities For Recruitment In The Digital Age10/20/2025
Health literacy gaps and online misinformation hinder clinical trial recruitment. Meeting patients where they are — digitally and educationally — can improve engagement and enrollment success.
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A Guide to Digital Endpoints in Respiratory Diseases4/15/2025
Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.
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The Future Of Regulatory Operations6/3/2024
The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.
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Transforming Regulatory Processes Through AI, ML, NLP, And RPAs4/7/2025
Explore the rapidly evolving landscape of regulatory processes as they undergo a profound digital transformation, highlighting how emerging technologies are reshaping traditional regulatory frameworks.
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Sickle Cell Cure Within Reach, But At A Steep Cost7/10/2025
Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How To Unlock The Secret To Repeatable, Scalable Low Turnover6/7/2024
Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.
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Recruitment To Screening: Bridging The Gap12/5/2025
Explore how providing tracked transportation for patients can streamline recruitment, improve site conversion rates, and deliver measurable ROI for clinical trials.
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Community Engagement vs. Digital Engagement For Higher Enrollment8/28/2024
Explore the importance of tailoring recruitment strategies to specific populations and leveraging diverse channels to reach potential participants.
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Digitizing And Standardizing Participant Pain Body Maps6/13/2024
Explore how digitizing clinical trial processes, such as paperless "body map" assessments, can enhance efficiency and standardization in pharmaceutical trials.
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Biotech Delivers A Superior Patient And Site Experience3/4/2025
To become the sponsor of choice for sites and patients in congenital hyperinsulinism clinical trials, a small biotech company prioritized delivering a superior experience while streamlining operations.
NEWSLETTER ARCHIVE
- 03.20.26 -- When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down
- 03.20.26 -- Helping Sites Tackle Complex Clinical Trials
- 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
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.
-
![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.
