After attending three Innovation Network Gathering Dive Teams, Chief Editor Dan Schell shares what he heard about accelerating study startup, rethinking investigator meetings, and leading through AI adoption—along with a reminder that promising ideas still need stakeholder support, measurable evidence, and practical execution.
- To Pick The Right Medical LLM, First Assess Your Readiness
- Can We Make Feasibility More Realistic?
- Your Company Needs Compliance Expertise — But When And From Whom?
- 5 Sponsor Contracting Issues That Delay Clinical Trials — And How To Avoid Them
- Participant Payment — Make It Make Cents
- What Ecological Momentary Assessment Taught Us About Real-World Hearing Outcomes
- Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System
GUEST COLUMNISTS
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Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System
Calidi’s Eric Poma, Ph.D., explains how CLD-401 could evade immune clearance — and how the biotech is designing Phase 1 to prove safety and efficacy fast.
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New Imaging Approach Could Improve IPF Trial Design
AI-powered quantitative CT could help sponsors detect treatment effects earlier, strengthen IPF trial endpoints, and make better go/no-go decisions.
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Most Patients Learn About A Trial Online, But Is That What They Want?
Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
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How Plain Language Summaries Created Under EU CTR Can Help Shape NIH Policy
As the NIH shapes its plain language summary policy, EU CTR experience offers practical lessons on clarity, privacy, consistency, and implementation.
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Long-Distance Rare Disease Trials: Why PLL Landed On Australia And New Zealand
Australia and New Zealand had a lot to offer PLL Therapeutics, but speed and savings aren't the only upsides for running its rare disease trial from its European home.
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Is Moving From One-Off Solutions To A Technology Platform The Best Fit For Your R&D?
Integrated technology platforms can connect R&D data, accelerate trials, strengthen quality, and cut costs — but successful adoption requires more than AI.
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How Digital Twins Are Reshaping Clinical R&D
Discover how digital twins are helping predict outcomes, streamline recruitment, reduce patient burden, and accelerate clinical development.
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Why Are We Still Talking About Compensating Research Participants?
Should we be compensating research participants? And is that even a question worth asking? Lindsay McNair, MD, and Ken Getz say yes despite recent data that doesn't point to a clear ROI.
CLINICAL TRIAL WHITE PAPERS
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UK Clinical Trial Regulations Reform
UK trial regulations have been overhauled. Learn what faster approval pathways, stricter publication rules, and longer retention requirements mean for your operations.
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Offline eCOA: The Real-Time Monitoring Dilemma3/9/2026
Balance the need for offline data safety with the necessity of real-time monitoring. Learn how to navigate new regulatory requirements for source devices while maintaining high patient compliance.
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Remote Patient Monitoring Using Mobile Health Technology3/28/2025
This study investigates the attitudes of cancer patients towards the adoption of mHealth technologies, including applications and wearable devices, for monitoring purposes during or after their treatment.
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Bringing Clinical Trials To Everyone's Backyard1/10/2025
Learn 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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Merits Of A Multifaceted Approach To Clinical Trial Recruitment1/27/2025
The best way to address clinical trial recruitment challenges is with a multifaceted approach that goes beyond traditional channels and ways of thinking.
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Collaborate To Improve The Patient Experience8/8/2026
Fragmented trial operations trigger costly enrollment delays. Discover how operational alignment among sponsors, CROs, and site networks drives patient retention and study success.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Relieving Pressure During Preparation Of A High-Volume sNDA5/27/2026
Managing a complex sNDA under pressure? See how one sponsor achieved an early FDA submission through coordinated publishing, regulatory strategy, and flawless execution.
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No More Swiss Holes: Filling The Gaps In Clinical Trial Disclosure1/14/2026
This use case shows how sponsors can gain clarity on disclosure requirements when entering a new country.
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Market Approval For A Novel Non-Hodgkin Lymphoma (NHL) Therapy4/11/2025
Explore a collaboration that underscores the importance of strategic planning and regulatory engagement in the approval process.
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Urgent Compliance Recovery Following Vendor Transition5/26/2026
Strong local leadership, clear ownership, and governed oversight drove rapid remediation of legacy safety gaps, restoring regulatory confidence and safeguarding market continuity.
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Improving Clinical Research Efficiency And Access For Underserved Populations3/26/2026
Modernizing data workflows removes geographic barriers to clinical trials, ensuring rural patients access innovative care while reducing administrative burdens on dedicated research staff.
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Leading Recruitment With A Strong Alzheimer's Referral Pool2/24/2026
A strong referral network helped the Gainesville site rapidly recruit pTau217‑positive Alzheimer’s participants while upholding high data quality, boosting enrollment and outperforming other sites.
NEWSLETTER ARCHIVE
- 10.13.26 -- AI-Powered Start-Up, Smarter FSP Partnerships, And Error-Proof Trial Tech
- 10.12.26 -- Why Oncology Programs Can't Rely On An Inside View Alone
- 10.10.26 -- Best Of September
- 10.09.26 -- Expertise That Scales: Trial Operations, Safety Signals, And HEOR Skills
- 10.09.26 -- From eConsent To Central eSource: Tools To Speed Startup And Lighten Site Work
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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Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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Participant payment practices and expectations vary wildly. With advocate T.J. Sharpe, explore why sponsors need to rethink how they appreciate participants' time, effort, and burden.
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Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.
FOCUS ON PATIENTS
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Could comprehensive health scans give trial participants meaningful value — and help sponsors reduce costly dropouts?
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Participant payment practices and expectations vary wildly. With advocate T.J. Sharpe, explore why sponsors need to rethink how they appreciate participants' time, effort, and burden.
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Patients want to hear about clinical trials from their doctors — but most learn out online. CISCRP explores how industry can change the referral pathway for better.