Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
- 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
- What BriaCell's Trial Design Says About Real-World Cancer Research
GUEST COLUMNISTS
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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.
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Everyone Is A Consultant Now
Jon Newton argues clinical research’s “vanishing middle” is giving rise to a more flexible workforce of consultants, specialists, and boutique firms.
CLINICAL TRIAL WHITE PAPERS
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Wearables For Optical Cardiovascular Monitoring
Wearable digital health technologies (DHTs) are transforming cardiovascular health monitoring by enabling continuous, real-world assessment through optical sensors like photoplethysmography (PPG).
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The Importance Of A Maturity Model For Clinical Trial Transparency10/23/2024
A comprehensive maturity model for clinical trial disclosure and transparency offers companies a strategic tool to assess and enhance their practices in an increasingly complex regulatory environment.
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Everest Group Life Sciences eCOA Peak Matrix Assessment 20259/16/2025
Discover how digital platforms are revolutionizing clinical trials by improving data quality and patient engagement in this comprehensive market assessment.
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Deriving Reliable Clinical Outcome Scores From Continuous DHT Data6/10/2025
DHT-derived endpoints, especially percentile-based metrics, hold promise for robust, scalable measurement in clinical trials—provided they're chosen statistically and with adherence in mind.
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UK Clinical Trial Regulations Reform7/24/2026
UK trial regulations have been overhauled. Learn what faster approval pathways, stricter publication rules, and longer retention requirements mean for your operations.
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The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event Detection11/7/2025
A proven, AI-powered safety platform can accelerate adverse event detection and safety data extraction to ease the burden on safety professionals and better protect patients.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Accelerating A Global, FIH ADC Therapy Trial For Lung Cancer11/17/2025
Choose a development partner who can navigate global execution, ADC-specific challenges, and Project Optimus requirements so your first-in-human study is designed and positioned for success.
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Successful EU MAA Submission Enabled By U.S.–EU Regulatory Collaboration5/27/2026
Facing EU MAA complexity? Learn how one oncology sponsor met a fixed EMA deadline through global regulatory coordination, rapid dossier adaptation, and real-time submission execution.
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Optimizing EDC Strategy And Data Collection for a Rare Disease Trial6/11/2025
Explore how Veristat created a forward-looking roadmap for EDC and CRFs integration for a small biotech sponsor, ensuring a future-ready data ecosystem without overcomplicating current operations.
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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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Top 10 Global Pharma Company Dramatically Improves Site Payments In Drive To Become Sponsor Of Choice10/30/2024
See how a pharma company reduced investigator payment cycle time by 55% while decreasing their own administrative burden by 90% in this metrics-rich case study.
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Leveraging A Demand-Led Clinical Supply Model For Program-Level Product Pooling3/12/2026
See how a global biopharmaceutical company was able to address inefficiencies and reduce waste within the clinical supply chain for a high-value therapy that faced strong demand but limited supply.
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.