Forecasting errors rarely start with the algorithm. They start when protocol changes, enrollment and site data reach the supply plan too late to prevent waste and disruption.
- Turning Pediatric Cancer Discoveries Into Medicines Requires Better Connections
- It Is Time To Require Human-Relevant Efficacy Evidence Before First-In-Human Trials
- Turning A Historically Limited Modality Into A Respiratory Drug Opportunity
- Building SIP Was The Hard Part
- Immune Priming, Oncolytic Viruses, And The Next Phase Of Solid Tumor Immunotherapy
- Accountability Gaps Can Break Clinical Supply Contracts
- 4 Ways That AI And Point-Of-Care Diagnostics Are Redefining Clinical Trial Design And Operations
GUEST COLUMNISTS
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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.
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Sustainable Patient Engagement: Your Enrollment And Representation Depend On It
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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Building The Execution Architecture For Real-World Data To Have Real-World Impact
RWE's next challenge is execution. Learn how life sciences orgns can turn evidence into sustained business and clinical impact.
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Stock Options: Choosing The Right Viral Inoculum For An Early-Phase Norovirus Trial
Viral stock can make or break a norovirus challenge study. Cocrystal Pharma's Sam Lee explains why inoculum quality, infectivity, and availability matter.
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The Reality Of Clinical Research Federal Funding Cuts
Although the most catastrophic federal funding cuts didn't come to fruition, Pamela Garzone discusses where some impacts are being felt now and will be felt for years to come.
CLINICAL TRIAL WHITE PAPERS
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The Renaissance Of Psychedelic Research: History, Protocols, And Forward Trajectories
Discover how clinical trial protocols are evolving to address unblinding, therapeutic support variables, and regulatory standards in modern psychedelic research.
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Empowering Mid-Size Pharma Companies With Integrated Drug Development, Regulatory Strategy, And AI Innovation10/23/2025
A consultative, tech-enabled CRO can help mid-size pharma achieve targets by supplementing skillsets, expanding global reach, and designing an effective clinical, regulatory, and operational strategy.
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The eCOA Iceberg5/27/2026
Understand the true cost of eCOA deployment, beyond software licenses, to reduce protocol risk, avoid operational bottlenecks, and protect study timelines and data quality.
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Decentralized And Community-Based Solutions Driving Women's Healthcare9/24/2025
Clinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
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2026 State Of Clinical Trial Technology: The Five Strategic Imperatives3/12/2026
AI acceleration and digital fragmentation are reshaping clinical trials. Discover five imperatives driving interoperability, smarter site enablement, and data‑ready workflows for future‑ready operations.
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What Is Healthcare Data Interoperability And Why Does It Matter For Clinical Research?1/28/2025
Explore how healthcare data interoperability can transform patient outcomes, streamline clinical research, and enhance efficiencies while addressing key challenges and global initiatives.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Retention And Access In NSCLC Clinical Trials5/12/2026
Helping participants navigate respiratory limitations, fatigue, and complex visit schedules in Non-Small Cell Lung Cancer (NSCLC) studies.
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Psychedelic Drug Trials: Are Your Sites Ready?8/24/2026
Psychedelic trials require unique operational approaches. Learn how to address patient safety, blinding, specialized assessments, and therapeutic setting considerations.
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Enhance Access And Improve Retention In Rare Disease Trials With HTS4/17/2025
Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
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Advancing Dose Escalation Strategies With Bayesian Modeling8/12/2025
A CRO was engaged to help a biotechnology sponsor develop a novel oncology therapy design and execute a multicenter, open-label Phase 1/2 dose escalation and expansion study in advanced solid tumors.
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Targeted Indication Selection Using Adaptive Design8/12/2025
What is a Simon 2-stage design, and how was it used to enable each tumor-specific cohort in a Phase 2, multi-cohort oncology trial to be independently assessed for objective response rates?
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Redefining Accessibility For Pediatric Patients9/24/2025
Explore how meeting patients where they are can redefine what successful pediatric trial delivery looks like.
NEWSLETTER ARCHIVE
- 08.29.26 -- Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials
- 08.28.26 -- From Data To Detection: Smarter Systems Are Reshaping Trial Oversight
- 08.28.26 -- Community Engagement, Travel Logistics, And Technology Driving Trial Success
- 08.27.26 -- What The FDA's Psychedelic Drug Focus Means For Classic Psychedelic Development
- 08.26.26 -- This WhichTrial Report Breaks Down The U.S. Clinical Trial Recruiting Pipeline
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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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.
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Skyhawk’s patient-first approach shows how advocacy partnerships, site engagement, and operational quality can accelerate enrollment without losing focus on patients.
FOCUS ON PATIENTS
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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?
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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.