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Breaking Through Tumor Defenses With Next-Generation Cell Therapy

Ernexa Therapeutics CEO Sanjeev Luther shares how clinical research has revealed why certain cancers resist treatment and how emerging cell therapies may help break through those defenses.

GUEST COLUMNISTS

When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs
Learn how to account for AI-related costs under evolving U.S. Generally Accepted Accounting Principles (GAAP).
FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now
On December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.
How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)
Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.
How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)
Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.
These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials
Minovia Therapeutics shares the importance of careful site selection, specialized operational expertise, multidisciplinary collaboration, and innovative trial design as it prepares for pivotal this year.
Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment
Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks.
What ChatGPT Ads Will Really Mean For Clinical Trials
AI health assistants may be used to surface clinical trials earlier in patient journeys, and advertising inside conversational AI is best understood as the next logical step in that same progression.
The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?
Despite the size and visibility of the community — and the call for diverse patient research — there remains a gap in available health data specific to the Sikh community in the U.S.

CLINICAL TRIAL WHITE PAPERS

Tracking Functional Capacity To Advance Neuromuscular Disease Research
This presentation introduces a dual-endpoint approach to monitoring neuromuscular disease progression through two high-centile digital measures.

Challenges And New Approaches To Developing Clinical Evidence For Medical Devices
9/12/2024

Learn about the challenges and new approaches to developing clinical evidence for medical devices, including decentralized trials, adaptive studies, in silico trials, and real-world evidence.
Addressing Trial Design Hurdles Across Alzheimer’s Disease Stages
12/10/2025

Explore how endpoint selection, rater training, and the strategic implementation of eCOA can help address the unique scientific, operational, and human considerations at each stage of AD.
How Sponsors Can Drive Success With Central eSource At Investigator Sites
6/17/2025

Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.
Digital Endpoint Resource Guide: Obesity And Related Metabolic Disorders
8/15/2024

Explore how digital health technologies can enhance obesity treatment by providing critical insights beyond weight loss.
Digital Endpoint Resource Guide: Rheumatology
3/19/2024

Explore how wearables and sensor-based technologies provide continuous, remote patient-centered outcomes, reducing trial participation burdens, increasing success probabilities, and enhancing condition management.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Optimizing Recruitment For Urgently Needed Vaccine
5/15/2024

Uncover how Citeline Connect helped a late-stage biotech sponsor expedite enrollment of a diverse population of eligible patients impacted by monkeypox for a large Phase 1 and Phase 2 trial of a next-generation vaccine.
Recruiting & Retaining More Patients Per Site:
3/14/2025

Through Home Trial Support (HTS) services, MRN is able to enhance the accessibility of clinical trials while reducing the emotional toll on their patients suffering from loss of mobility.
Expanding Access To Post-Market Safety Exams For Cystic Fibrosis Medication
1/29/2025

This study highlights the transformative impact of point-of-need care on patient access, focusing on pediatric cystic fibrosis (CF) patients requiring essential eye exams.
A Long COVID Study Sponsor Adopts Integrated eCOA And Cognitive Assessment Solution
8/18/2025

eCOA tools used in a long COVID study enabled remote, real-time symptom tracking, cognitive testing, and patient-reported outcomes, ensuring high-quality data while minimizing patient burden.
CRO Uses CRIO eSource To Double Monitoring Productivity
1/31/2025

Examine the transformative impact of eSource technology on monitoring productivity during a global Phase 3 trial conducted by a Contract Research Organization (CRO) amid the COVID-19 pandemic.
Transforming Clinical Supply Planning From Spreadsheets To Smart Forecasting
11/17/2025

Streamline your clinical supply forecasting and reduce risk by moving beyond manual spreadsheets to an integrated, real-time supply management solution.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

More Newsletters

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.

The Problem With Excluding Children From GLP-1 Trials In The U.S.

In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.
4 Steps For Representative Enrollment In Rare Disease Trials

Discover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.

FOCUS ON PATIENTS

Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease

The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.
The Problem With Excluding Children From GLP-1 Trials In The U.S.

In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.
How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.