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.
- 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
- Do We Still Need To "Save" Our Sites?
- When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down
- How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026
GUEST COLUMNISTS
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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.
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![bayesian stats image-GettyImages-1205583077]( "FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs")
FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small BiotechsThe FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.
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![Climate Change-GettyImages-2151025853]( "Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial")
Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology TrialDiscover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.
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![AI-Artificial Intelligence in Healthcare-GettyImages-1365534802]( "The Uncomfortable Conversation: AI And Data Use In Clinical Trials")
The Uncomfortable Conversation: AI And Data Use In Clinical TrialsAI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-953782406-digital-patients-people-recruit]( "Transforming Effective Patient Recruitment Within The Changing Health Care Landscape")
Transforming Effective Patient Recruitment Within The Changing Health Care LandscapeRevolutionize patient enrollment by closing the "95% gap." Explore an approach that uses digital health and data-driven insights to engage diverse populations where they live.
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Serbia: Europe's Emerging Clinical Trial Powerhouse1/22/2026
Discover why Serbia is becoming a top strategic choice for sponsors, including details of the country's strengths in key therapeutic areas, streamlined processes, and operational advantages.
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State Of Clinical Trial Technology: The AI Inflection Point2/12/2026
Digital maturity gaps are widening in clinical research. Connected workflows speed insights and execution, while manual processes leave organizations increasingly behind.
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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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Potential Of eClinical Solutions To The Complexity Of Oncology Trials7/31/2025
How are eClinical technologies—specifically IRT and eCOA— being leveraged to overcome patient recruitment difficulties, high mortality rates, and the intricacies of cancer treatments.
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Decentralized And Community-Based Solutions Driving Women's Healthcare9/24/2025
Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Tailored Approach Supports Bladder Cancer Breakthrough3/5/2026
Discover how a flexible operational strategy and expert site management help bladder cancer programs overcome complex logistical hurdles and achieve critical regulatory milestones.
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Analytics–Powered Approach To Patient Recruitment Strategy7/15/2025
In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.
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Data Key In Addressing Patient Recruitment Challenges6/19/2025
Explore how a Phase II trial for extensive-stage and previously treated small cell lung cancer overcame recruitment challenges with a data-driven solution designed to surface protocol-matched patients.
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Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice10/30/2024
See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.
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GxP Inventory Solution Delivers Real-Time Visibility, Operational Efficiency12/10/2025
Explore how unified forecasting and GxP-level inventory control can streamline your clinical supply chain, reduce risk, and strengthen oversight across every trial you run.
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Rescuing A Global Full-Service Phase III Trial For A Late-Stage Oncology Biotech10/2/2025
This case underscores the expertise employed in a comprehensive strategy and set of services that were used to salvage a Phase III clinical trial for ovarian cancer and ensure its timely completion.
NEWSLETTER ARCHIVE
- 03.17.26 -- AI In Clinical Trials What's New And What's Hype
- 03.16.26 -- Site-Centric First, Patient-Centric Always
- 03.14.26 -- Clinical Leader Best Of February
- 03.13.26 -- The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board
- 03.12.26 -- Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes
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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![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.
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![Chat bot service, future marketing-GettyImages-1468141962]( "When A Clinical Trial Surfaces In An AI Chat, What Happens Next?")
AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
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.
