Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.
- CROs, AI, And The New Economics Of Outsourcing
- Don't Let The Nocebo Effect In Psychedelic Trials Become A Regulatory Problem
- Are You Liable? What All Clinical Stage Companies Should Understand About Risk Disclosure
- How Important Are Medical Monitors Under ICH E6(R3)?
- Old Habits, Communication Issues Still Stalling Site Budget Negotiations
- The Art Of Finding And Keeping The Right KOL
- What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman
GUEST COLUMNISTS
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![Gold key hung in the middle-GettyImages-1310224740]( "The Art Of Finding And Keeping The Right KOL")
The Art Of Finding And Keeping The Right KOLLearn 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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![Success Transformation, improvement, leadership-GettyImages-1417761158]( "What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman")
What To Look For In Rare Disease Partnerships, With Origami's Beth HoffmanOrigami 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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![Person Donating Blood-GettyImages-2246332353]( "Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic")
Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The ClinicTr1X Bio Co-founder and CEO David de Vries explains how moving Type 1 regulatory T Cell (Tr1) therapies into new indications reshapes every facet of first-in-human trial design.
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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")
PolarityBio Loosens I/E And Taps Many Provider Types To Reach More PatientsDiscover 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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![OpenAI ChatGPT, Google Gemini, and Anthropic Claude-GettyImages-2203181438]( "FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To Know")
FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To KnowForced to cease using Anthropic's Claude for its Elsa generative AI assistant, the FDA is switching to Gemini. Legal experts Kimberly Chew, Esq., and Michael Yang, Esq., explain the implications for trade secrets and data security risks.
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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.
CLINICAL TRIAL WHITE PAPERS
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![GettyImages-1492337134 doctor notes]( "Elevating Patient Centricity In Clinical Trials")
Elevating Patient Centricity In Clinical TrialsHow can the integration of patient perspectives throughout the clinical trial process enhance engagement and outcomes?
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The Impact Of High Inflation And The Great Resignation On Clinical Site Budgeting10/30/2024
The twin pressures of inflation and attrition prolong negotiations between sponsors and clinical sites, stalling drug development. Sponsors need up-to-date, reliable benchmark data to negotiate fair market value budgets.
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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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Designing More Representative Trials Through Strategic Planning5/28/2025
Strategic planning for representative clinical trials improves outcomes, regulatory alignment, recruitment efficiency, and commercial value by ensuring study populations mirror real-world patients.
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Practical Strategies For Diverse Trial Recruitment11/11/2024
The clock is ticking on the requirement for pharmaceutical companies to include FDA-mandated diversity action plans for pivotal studies in clinical trials.
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RWD, New Technologies Show Potential In Clinical Trial Recruitment7/10/2025
Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Fulfilling MDR Requirements For A Groundbreaking Microsurgery Robot8/19/2024
Discover the help a company pioneering the field of open surgery received to advance their robotic technology, replacing their former EDC system to improve their clinical research efficiency.
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Phase 1 Trial In Painful Diabetic Peripheral Neuropathy2/24/2026
A complex Phase 1 neuropathy study with overnight stays achieved full enrollment and retention through careful planning, strong participant engagement, and disciplined operational execution.
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Optimized Processes: A Guide To Lyophilization Cycle Development6/25/2024
Review the essential phases of the lyophilization cycle — freezing, primary drying, and secondary drying — and critical success factors to achieve optimal product quality and stability.
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Electronic Body Maps Drive Standardization Across Top-10 Pharma7/8/2024
Learn how a top-10 pharmaceutical client was able to "fundamentally transform the way they execute clinical trials" with the digitization and standardization of pain maps in a diabetic polyneuropathy trial.
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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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Expanding Clinical Research In East Africa With Digital Innovation12/11/2025
Africa carries 25% of the world’s disease burden but hosts only 1% of clinical trials. Discover technology-driven strategies that close this gap and transform research access in underserved regions.
NEWSLETTER ARCHIVE
- 03.25.26 -- U.S. Pharma Tariffs And MFN: Manufacturing And Procurement Impact
- 03.25.26 -- STREAM Edition: 3 Pillars Of Trustworthy AI In Clinical Trials
- 03.24.26 -- The Uncomfortable Conversation: AI And Data Use In Clinical Trials
- 03.23.26 -- SCOPE Takeaways On Inclusion And Real Patient-Centricity
- 03.20.26 -- When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down
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.
-
![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.
-
![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.
-
![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.
