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.
- 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?
- How Digital Twins Are Reshaping Clinical R&D
- Why Are We Still Talking About Compensating Research Participants?
- Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's
GUEST COLUMNISTS
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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.
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The U.S. Clinical Trial Recruiting Pipeline Report – August 2026
This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from July and August.
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How VNS-REHAB Aims To Improve Stroke Recovery After Patients Have Plateaued
Learn how a stroke trial standardized intensive therapy, sustained patient adherence, and exposed access barriers after FDA approval.
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Resensitizing Treatment-Resistant Cancer Holds Promise Over Replacing Once-Efficacious Therapies
John Yu, MD, of Kairos Pharma, explains why reversing treatment resistance could extend the life of proven cancer therapies and improve patient outcomes.
CLINICAL TRIAL WHITE PAPERS
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The Impact Of High Inflation And The Great Resignation On Clinical Site Budgeting
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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The Silent Saboteurs: Why Rater Drift And Site Unpreparedness Cost CNS Trials More3/25/2026
High-end technology cannot fix poor rater preparation or complex patient needs. True data integrity requires bridging the gap between digital platforms and the reality of clinical implementation.
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Navigating Complexity In Master Protocols With Key Operational Partners7/5/2026
Complex adaptive trials offer real efficiency gains, but success hinges on having experienced partners to manage the operational details.
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A New Approach To Dynamic Clinical Oversight With Centralized Insights7/10/2025
RBQM is transforming clinical trial oversight. By automating protocol digitalization, site selection, and risk assessments 360° Monitoring enables the proactive identification of CtQ factors.
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The Complexities Of Effective Patient Retention In Clinical Trials11/7/2025
Identifying and enrolling the right-fit patients from the outset is essential, but so is implementing comprehensive retention strategies that prioritize patient comfort, trust, and ongoing engagement.
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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Drive Superior Enrollment, Speed, And Quality Using eSource1/3/2025
Explore a detailed analysis of 140 research sites involved in a Phase III trial, highlighting significant advancements in trial performance and data quality using CRIO’s eSource platform.
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Expanding Access To Post-Market Safety Exams For Cystic Fibrosis Medication1/29/2025
This study highlights the transformative impact of point-of-need care on patient access, focusing on pediatric cystic fibrosis (CF) patients requiring essential eye exams.
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Launching A Unified Global Sales Team In 90 Days11/7/2025
A global CRO united 300+ sales and executive leaders across five continents for a dynamic, space-themed meeting that strengthened culture, deepened product understanding, and inspired alignment toward annual growth goals.
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FDA Approvals Of Two Novel Agents For The Acute Treatment Of Migraine7/31/2026
Parallel trials, compressed timelines, thousands of patients. Discover the data oversight strategies that kept two programs on track to approval
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Advancing Neuromuscular Research with Digital Endpoints1/20/2026
Explore cutting-edge digital measures that capture peak mobility and activity in real-world settings, offering meaningful insights into disease progression in neuromuscular disorders.
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Unlocking Recruitment Potential In Trial-Naïve Sites4/17/2025
Site Professional Support enabled this late-phase rheumatoid arthritis study to conduct complex patient visits despite its use of sites that lacked research experience and resources.
NEWSLETTER ARCHIVE
- 10.02.26 -- Sponsors Are Automating Trials With AI — But Can They Trust The Output?
- 10.01.26 -- Health Policy Is Shifting Fast — Is Your Compliance Strategy Keeping Pace?
- 10.01.26 -- Better Site Support Starts Early
- 09.30.26 -- Old Trial Playbooks Are Breaking Under New Complexity
- 09.30.26 -- Inside: Patient Advocacy, Smarter RTSM Builds, And Tech That Cuts Costs
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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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.
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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.
FOCUS ON PATIENTS
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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.
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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.