CTA negotiations don’t have to stall study start-up. Learn five sponsor-side contracting issues that cause delays and practical ways to prevent them.
- Calidi's Study Aims To Have An Oncolytic Virus Outsmart The Immune System
- With CROs, Decide What You Can Actually Manage
- New Imaging Approach Could Improve IPF Trial Design
- Most Patients Learn About A Trial Online, But Is That What They Want?
- How Plain Language Summaries Created Under EU CTR Can Help Shape NIH Policy
- Long-Distance Rare Disease Trials: Why PLL Landed On Australia And New Zealand
- Is Moving From One-Off Solutions To A Technology Platform The Best Fit For Your R&D?
GUEST COLUMNISTS
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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.
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Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's
P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.
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The 50-Page Monitoring Report And The Illusion Of Control
A massive decentralized trial showed why more monitoring doesn’t always mean more control — and how risk-based oversight can reveal what truly matters.
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Autoimmune Drugs For Women: What To Bring To The Clinic
Autoimmune disease is one of the most sex-skewed categories in medicine. Sex, reproductive status, and hormonal state should not be treated as background noise.
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The Real Cost Of Sites Working Without An Enforceable Agreement: Why Your Site's Quality Of Earnings Is Suspect
Starting site work before an enforceable agreement may look like flexibility, but it can drain leverage, create unrecoverable costs, and raise financial reporting and GCP concerns.
CLINICAL TRIAL WHITE PAPERS
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Proving The Return On Investment For eRegulatory
Explore a study of how leading research centers, CROs, and sponsors cover the cost of eRegulatory tools … and then some.
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Routes To Sponsor Of Choice: Shared Pipelines, Streamlined Payments10/30/2024
Paying clinical trial sites consistently on time provides stability and maintains positive relationships. Learn why being a sponsor of choice can mean the adoption of a singular clinical trial payments solution.
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Optimizing Site Activation To Accelerate Clinical Trials6/5/2025
Clinical trial site activation delays are a major bottleneck in drug development, hampering trial timelines and funding flows. To reverse this trend, site-focused solutions are being prioritized.
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Rethinking Trial Access Through Trust-Driven Design And Local Collaboration5/19/2026
Locally embedded research models help sponsors reach underserved populations while reducing burden on patients and health systems alike.
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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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Strategic Implications Of The Single Phase 3 Approval Paradigm7/21/2026
As FDA single-trial approvals gain traction, CNS developers need stronger early evidence. Learn how biomarkers, patient selection, and regulatory strategy can accelerate development.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Transforming Ophthalmic Assessments For A Mid-Trial Protocol Change7/9/2026
Discover how a biopharmaceutical company integrated urgent mid-trial mandates across 65 sites, cutting standard onboarding timelines in half while preserving critical enrollment milestones.
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A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution8/18/2025
eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
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Enhancing Phase 1 Clinical Trials With Point-Of-Need Safety Assessments2/3/2025
A Mobile Clinical Suite (MCS) proved to be the solution that Syneos Health needed to resolve their Phase 1 study trial challenges with comprehensive eye exams.
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Quantitative ROI With DCTs11/13/2025
Through dedicated staffing, operational oversight, and collaboration with site teams, see how we were able to transform a struggling cardiology study into a revitalized recruitment effort.
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Continuity And Risk Mitigation Following Unexpected QPPV Resignation5/26/2026
Rapid escalation and clear interim governance ensured compliance and operational continuity following an unexpected QPPV resignation, reducing inspection risk during a critical pharmacovigilance transition.
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Turning Patient Advocacy Into Meaningful Trial Engagement8/18/2026
See how structured PAO engagement can inform protocol design, reduce participation barriers, and strengthen recruitment and retention.
NEWSLETTER ARCHIVE
- 10.07.26 -- Investigator Responsibilities In Decentralized Clinical Trials
- 10.07.26 -- Where RWE Is Still More Hype Than Reality
- 10.06.26 -- Early Drug Effects Missed, Trial Workloads Underestimated
- 10.06.26 -- Clinical Insights For An Evolving Drug Development Landscape
- 10.05.26 -- Why Are We Still Talking About Compensating Research Participants?
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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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.
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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.
FOCUS ON PATIENTS
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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.
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As the NIH shapes its plain language summary policy, EU CTR experience offers practical lessons on clarity, privacy, consistency, and implementation.