Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.
- How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure
- The SIP Problem Is Bigger Than SIP
- Lessons In Forecasting Discipline From A $40B Supply Chain
- The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option
- Planning A Global Clinical Trial With The Right Sites, Not The Most Sites
- Turning Pediatric Cancer Discoveries Into Medicines Requires Better Connections
- Building SIP Was The Hard Part
GUEST COLUMNISTS
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Turning Pediatric Cancer Discoveries Into Medicines Requires Better Connections
Promising pediatric cancer science often stalls before patients benefit. David Adler explains how better connections could change that.
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Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
How can sponsors revive a promising modality with known safety limits? Vast Therapeutics CEO Nate Stasko, Ph.D., explains how ALX1 is reshaping nitric oxide delivery.
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It Is Time To Require Human-Relevant Efficacy Evidence Before First-In-Human Trials
Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?
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Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy
Can priming with oncolytic viruses be a better path to reeducating the immune system to recognize and attack cancer? Oncolytics Biotech advisor Richard Vile, Ph.D., says yes.
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4 Ways That AI And Point-Of-Care Diagnostics Are Redefining Clinical Trial Design And Operations
Discover how AI-enhanced point-of-care diagnostics are changing trial design and what ClinOps should do next.
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What BriaCell's Trial Design Says About Real-World Cancer Research
BriaCell President and CEO William Williams, MD, shares how broader eligibility criteria and physician’s choice controls can better reflect real-world cancer care.
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Accountability Gaps Can Break Clinical Supply Contracts
Contract gaps can create clinical supply failures when responsibilities differ across agreements. See how aligning obligations can prevent costly disputes, delays, and risks.
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'How Do You Feel?': Designing A Cardiac Trial With A Patient-Reported Primary Endpoint
Imbria Pharmaceuticals' Albert Kim, MD, Ph.D., shares why PROs are the point of the company's FORTITUDE-HCM trial for patients with non-obstructive hypertrophic cardiomyopathy.
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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Safeguarding Personal Data: Protecting PII8/4/2025
Learn about a secure, patient-centric platform that enables individuals to participate in clinical trials and registries while maintaining lifelong access to their data.
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The EMR Interoperability Dream Vs. Clinical Research Reality10/20/2025
Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.
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New Duke Research Shows Participants Prefer Enhanced eConsent10/7/2024
It’s apparent to those who have used it that the “e” in eConsent could stand for much more than 'electronic'. Duke’s new research shows why participants prefer an eConsent experience bolstered with videos, media, questions, and more.
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Navigating The Challenges Of Large, International Phase III Breast Cancer Trials5/27/2026
In the competitive landscape of breast cancer research, aligning biomarker testing, regulatory pathways, and regional operations from day one creates a path to faster enrollment and stronger outcomes.
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The Real Cost In CNS Trials: Rater Drift And Site Readiness11/21/2025
Learn how to build resilience into CNS trial operations with evidence-based frameworks that prioritize human factors alongside digital tools.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Recruitment To Screening: Bridging The Gap12/5/2025
Explore how providing tracked transportation for patients can streamline recruitment, improve site conversion rates, and deliver measurable ROI for clinical trials.
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How Cara Therapeutics Increased Compliance And Reduced Study Team Burden7/31/2025
Delve into the partnership that helped Cara Therapeutics achieve a significant milestone in their clinical research efforts to transform the lives of chronic pruritus patients.
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Digital Outcome Measures Approved As Primary Endpoint In Cardiopulmonary Study4/15/2025
Discover how a clinical development program was saved using objective, continuous digital outcome measures.
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Sensors And On-Demand eCOA7/13/2026
See how one rare disease trial eased caregiver burden by unifying glucose monitoring and patient diaries into a single app with real-time safety alerts.
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Transforming Clinical Trial Sites With Research Study Rockstar2/10/2025
This innovative platform streamlines workflows, automates patient communication, and provides intuitive dashboards to address prevalent pain points faced by trial coordinators.
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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.
NEWSLETTER ARCHIVE
- 09.02.26 -- Can Digital Endpoints Really Accelerate Clinical Trials?
- 09.02.26 -- This Isn't Just A Compliance Exercise
- 09.01.26 -- Cut The Chaos: Smarter Systems For Sites, Sponsors, And Data
- 08.31.26 -- Compassion Shaping Pediatric Rare Disease Trials
- 08.29.26 -- Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials
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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AI can explain your trial — but can it help patients act? Ross Jackson shares how sponsors can turn visibility into trust and next steps.
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Early and ongoing patient engagement is a crucial component to staving off recruitment trouble and securing proper patient representation. Boehringer Ingelheim's Karen Correa, Ph.D., explains how.
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When designing and conducting trials for terminally ill patients, Kamila Novak reminds researchers to act and speak with respect, warmth, and thoughtfulness.
FOCUS ON PATIENTS
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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.
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Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
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Why, when human-relevant evidence of likely efficacy can be generated before a trial begins, is it not evaluated before patients are exposed?