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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De-Risking The Neurology IND: Lessons From Early FDA Engagement
Learn how early FDA alignment can help your neurology program move forward with greater clarity, confidence, and regulatory readiness.
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Transforming Regulatory Processes Through AI, ML, NLP, And RPAs4/7/2025
Explore the rapidly evolving landscape of regulatory processes as they undergo a profound digital transformation, highlighting how emerging technologies are reshaping traditional regulatory frameworks.
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A Guide To Digital Endpoints In Major Depressive Disorder3/7/2025
The integration of digital health technologies (DHTs) in clinical trials for Major Depressive Disorder (MDD) is transforming how symptom severity and treatment efficacy are measured.
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US Healthcare System Overview4/29/2026
A clear guide to U.S. coverage, regulation, and reimbursement: who decides care, how products gain access, and how policy and financing shape cost, value, and patient access.
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ICH E6(R3) Annex 2: Navigating GCP Requirements For Decentralized Trials7/24/2026
Implementing decentralized components or real-world data requires proactive alignment with updated GCP standards for data access, remote consent, and multi-stream investigator oversight.
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Agentic AI And How It's Impacting Clinical Trial Research7/7/2025
Since ChatGPT’s launch in 2022, artificial intelligence has transformed industries worldwide—but the next evolution, Agentic AI, promises to be even more profound.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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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.
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Finding An RTSM Software To Keep Up With A Small Biotech3/26/2026
Stop letting rigid RTSM builds stall your oncology trials. Learn how agile configuration and right-sized documentation keep Phase I studies on track during frequent protocol amendments.
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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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Reinventing Prostate Cancer Diagnostics With An All-In-One Platform3/31/2026
Discover how a lean research team saved an estimated $100k and reached 95% data compliance by unifying their clinical workflow.
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Reserving Data Integrity With Retrospective Manual Entry7/5/2026
A look at implementing randomization mid-trial by reconstructing subject and inventory records without disrupting sites or compromising data integrity.
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Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays9/25/2025
Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
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.