Clinical trial standards are essential. But to interpret changes, preserve meaning, and assess downstream impact, context is key.
- Turn AI Visibility Into Action: Build Explanation Layers For Different Stakeholders
- 5 Ways To Enrich The Clinical Trial Ecosystem
- The Promise Of MRD-Guided CAR-T Treatment
- Your Trial Shows Up In AI. Now What?
- Dose Escalation, Combination Strategy Keep Aprea Ahead In Its Oncology Trials
- How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure
- The SIP Problem Is Bigger Than SIP
GUEST COLUMNISTS
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How A $96M Gift Is Transforming Pediatric Brain Cancer Clinical Trial Infrastructure
By pairing donor priorities with research needs at Children's National, Milken Institute SPARC is turning philanthropy into faster trials, stronger infrastructure, and long-term care goals.
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Lessons In Forecasting Discipline From A $40B Supply Chain
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.
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The Pharmacy Benefit No One Is Managing: Clinical Research As A Care Option
Pharmacies could make trials more accessible — if they preserve patient trust while research partners handle the operational burden.
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Planning A Global Clinical Trial With The Right Sites, Not The Most Sites
Less is more for Yi Larson and the team at Excursion Therapeutics, which opted to build right site network — not the largest one — for its Phase 2 trial.
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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.
CLINICAL TRIAL WHITE PAPERS
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Beyond A Single Disease: Traversing Complexity In Breast Cancer Clinical Development
Biomarkers, new therapies, and tough enrollment hurdles are reshaping breast cancer trials. Get the insights to plan smarter.
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Developing Next-Generation Therapies For Breast Cancer Patients9/8/2026
Breast cancer trials span multiple subtypes and modalities. Learn how specialized oncology experience helps reduce enrollment risk and keep programs on track.
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Go From Three Meetings To One With AI-Enabled eCOA5/5/2026
Learn how to turn three meetings into one with AI that is streamlining clinical workflows by reducing redundant steps, simplifying site operations, and accelerating data collection.
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Human-Centered RTSM Design Enhances Data, Safety, And Operations12/5/2025
Uncover how this human-centered approach to RTSM prioritizes user experience (UX) and interface design (UI) to reduce complexity, minimize errors, and improve compliance.
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Unique IRT Implementation Considerations For Personalized Medicine Trials8/22/2025
The rise of personalized and precision medicine is reshaping the clinical trial landscape and, as the number of these specialized trials increases, so does the complexity of managing them effectively.
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Rethinking Trial Access Through Trust-Driven Design And Local Collaboration5/19/2026
Locally embedded research models help sponsors reach underserved populations while reducing burden on patients and health systems alike.
CLINICAL TRIAL APP NOTES & CASE STUDIES
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Delivering A Registrational GI Trial Through Ongoing Protocol Shifts10/17/2025
A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.
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Supporting Study Set Up In Just 4 To 6 Weeks3/4/2025
Facing challenges in cycle times, quality control, and visibility, a global CRO adopted Medidata’s Rave Imaging, integrating it with its existing Rave EDC system to create a seamless digital workflow.
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Packaging And Labeling Support For A Global Cell Therapy Program8/10/2026
Master complex cell therapy logistics with coordinated depots, purpose-built labeling, and temperature-controlled solutions that protect product integrity.
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Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
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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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Scaling Global Vaccine Mega-Trials For A Top Five Pharma4/16/2026
See how high-volume enrollment, dynamic safety data capture, and rapid iteration can support global studies operating under intense timelines and scale.
NEWSLETTER ARCHIVE
- 09.08.26 -- Purpose-Built Beats All-In-One: Smarter Tech For Trial Data, Imaging, And Site Work
- 09.04.26 -- Data Accuracy Meets Patient Access: Innovations Driving Clinical Trials Forward
- 09.04.26 -- From Intelligent RTSM To Inspection Readiness: Smarter Clinical Workflows
- 09.03.26 -- Faster FDA Pathways, Smarter Partnerships: Rethinking How Trials Get Done
- 09.03.26 -- Finding The Right Trial Model For Better Study Outcomes
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 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.
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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.
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?