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
- New Imaging Approach Could Improve IPF Trial Design
- With CROs, Decide What You Can Actually Manage
- How Plain Language Summaries Created Under EU CTR Can Help Shape NIH Policy
- Most Patients Learn About A Trial Online, But Is That What They Want?
- 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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Global Trial Disclosure Landscape Grows Increasingly Complex
The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.
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What Re-Acquisition In Retinal Imaging Is Really Costing Your Program4/6/2026
High screen failure rates and patient dropout often stem from preventable imaging errors. Learn how proactive quality control and patient-centric logistics secure critical retinal trial data.
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Futureproofing Post-Approval Compliance4/15/2026
In the post-approval stage, a synergistic operating model brings PV and regulatory functions under one umbrella: a single governance structure with shared decision cycles, templates, and evidence.
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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.
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Accelerate Drug Development With Master Protocols5/15/2025
Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.
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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.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Accelerating Approval Pathway For Phase III Ovarian Cancer Trial8/29/2025
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
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Accelerate Your Oncology Breakthroughs4/16/2025
Finding the right partnership can help your oncology clinical trials overcome trial complexities through strategic planning, a deep scientific understanding, and operational excellence.
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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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Trial Rescue And Reconnaissance4/15/2026
Explore a strategic partnership that resulted in a rescue plan for a Phase III oncology trial that was facing high site decline rates.
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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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Strategic Pre-IND Consulting For Gene Therapy In Rare Leukemia4/11/2025
Learn about the collaborative efforts of an innovative biotech startup and Ergomed Consulting to overcome challenges in the pre-IND phase for a novel gene therapy targeting a rare form of leukemia.
NEWSLETTER ARCHIVE
- 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?
- 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?
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.