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.
- Why Are We Still Talking About Compensating Research Participants?
- Examining The Potential Of P-tau217 To Provide Earlier Diagnosis Of Alzheimer's
- The 50-Page Monitoring Report And The Illusion Of Control
- Small Biotech Can Outsource The Work, But Not The Thinking
- Autoimmune Drugs For Women: What To Bring To The Clinic
- The Real Cost Of Sites Working Without An Enforceable Agreement: Why Your Site's Quality Of Earnings Is Suspect
- The U.S. Clinical Trial Recruiting Pipeline Report – August 2026
GUEST COLUMNISTS
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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.
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Why Oncology Programs Can't Rely On An Inside View Alone
Discover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.
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In Case You Missed Them: Recapping The FDA's Recent Guidances For Cell And Gene Therapies
I review 10 of the FDA’s guidances spanning the last 12 months, all of which aid cell and gene therapy companies to assure safety and efficacy of these medicines.
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Repurposing Three FDA-Approved Drugs For A New Stroke Recovery Strategy
When three drugs become one — the polypharmacology strategy, 505(b)(2) pathway, and objective endpoints Nuero-Innovators is relying on to bring new hope to stroke patients.
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Coalition Takes Guesswork Out Of Charcot-Marie-Tooth Disease Research With New Guidance
A new Charcot-Marie-Tooth guidance introduces practical recommendations to help sponsors design clearer, more patient-centered, regulator-ready trials.
CLINICAL TRIAL WHITE PAPERS
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A Practical Guide To Harnessing The Value Of APAC For Global Trial Success
As Phase III costs and complexity rise, APAC offers faster enrollment, lower costs, and market access advantages, but capturing that value requires early planning and in-region expertise.
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Breaking Through Barriers With Integrated Trial Optimization5/9/2025
In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.
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The Evolution Of SDV, SDR, And RBQM In Clinical Trial Data Quality11/18/2024
Explore the inefficiency of complete SDV and how the adoption of technologies like centralized monitoring, remote SDR, and targeted SDV can enhance data integrity and cost-effectiveness.
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Navigating Adverse Immunostimulation: A Practical Guide For Clinical Researchers9/30/2025
Explore a systematic approach to evaluate adverse immunostimulation (AIS) in drug development through standardized biomarker sampling and tailored management strategies.
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Tracking Functional Capacity To Advance Neuromuscular Disease Research2/6/2026
This presentation introduces a dual-endpoint approach to monitoring neuromuscular disease progression through two high-centile digital measures.
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Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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How A Small Biotech Partnered With Us To Navigate Trial Complexity With Confidence And Control7/30/2026
Early-phase trials often evolve rapidly. See how a flexible RTSM approach helped a biotech sponsor manage major protocol changes without disrupting study execution.
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FDA Fast-Tracked Clinical Trial7/9/2026
Deconstruct the enrollment bottleneck in an ophthalmic gene therapy trial, discovering how point-of-need pre-screening cuts site activation delays and accelerates clinical development timelines.
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Expand Bandwidth With A Trusted Regulatory Writing Partner9/18/2025
Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.
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Flexible Data Management For Growing Portfolio7/31/2025
Explore strategic enhancements to a small biopharma's biometrics capabilities involving the deployment of 20 specialized professionals, which effectively bolstered the client’s organizational capacity.
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Increasing Efficiency And Reducing Drug Waste10/2/2025
Discover how streamlined clinical supply chain management helped accelerate study timelines, reduce costs, and support global treatment delivery through a strategic technology partnership.
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Advancing Rare Disease Clinical Trials With Point-Of-Need Eye Assessments1/29/2025
During the COVID-19 pandemic, Applied Genetic Technologies Corporation (AGTC) faced significant hurdles in enrolling participants due to travel restrictions and site limitations.
NEWSLETTER ARCHIVE
- 09.29.26 -- Sponsors Are Rethinking Payments, eSource, And Study Design — Are You?
- 09.28.26 -- The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option
- 09.25.26 -- Sponsors Trust AI To Match Patients — But Risk Still Needs Human Eyes
- 09.25.26 -- Stop Chasing Documentation. Let Trial Software Catch Up Instead
- 09.24.26 -- Why ING Feels Different
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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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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AI visibility isn’t just about being found. Ross Jackson coaches sponsors on how to influence AI to provide clear stakeholder pathways for clinical trial involvement.
FOCUS ON PATIENTS
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Discover how looking outside a program can help oncology teams test assumptions, improve feasibility, and make stronger development decisions.
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Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.