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The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development

Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

GUEST COLUMNISTS

When A Clinical Trial Surfaces In An AI Chat, What Happens Next?
AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
The Cost Of Transactional Thinking In Clinical Research
Denise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.
Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1)
Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.
Safe And Sustainable DCTs and Hybrid Trials (Part 2)
In part two of this series, learn practical cloud architectural patterns, governance structures, and operating mechanisms that allow sponsors to run hybrid and decentralized trials.
Why Sponsors Should Share KPI Rationale With Sites
To build partnerships, foster transparency, and promote shared accountability, Curo Research CEO Amy Bland explains why sponsors need to communicate the utility of KPIs with sites.
Rethinking Clinical Trials In Rare Neurodegenerative Diseases: Lessons From Alterity's MSA Trial
Alterity Therapeutics CEO David Stamler shares how early diagnosis, biomarker-guided design, and precise patient selection positively impacted a trial in multiple system atrophy (MSA).
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.
Reprogramming The Tumor Microenvironment: Bringing A Metabolic Checkpoint Therapy Into The Clinic
Pilatus Biosciences CEO Raven Lin shares learnings from his company's early-stage oncology program.

CLINICAL TRIAL WHITE PAPERS

Empowering Transformation Through Technology
By outlining the transformation of clinical data management into data science, this paper highlights the growing responsibility of data managers as stewards of all clinical trial data and its overall quality.

What Is ICH GCP, And How Does It Impact Clinical Planning?
10/20/2025

The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.
Disclosure Management System: Build Or Buy?
6/19/2025

Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.
Navigating The FDA's Drug Supply Chain Security Act
3/14/2025

Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.
How AI Is Reshaping Trial Design, Execution, And Disclosure
9/25/2025

AI has quietly embedded itself into the operational heart of clinical development, where it is accelerating decisions, reducing manual burden, and improving outcomes.
Patient-Focused Data Capture For Cancer Research
8/21/2025

In a field where innovation is constant and patient experience is pivotal, oncology demands eCOA solutions designed to balance scientific rigor with human realities.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Supporting Participants Through National Travel Disruptions
12/10/2025

A sudden travel shutdown threatened a critical clinical visit. Rapid rescheduling, coordinated logistics, and clear communication ensured engagement and the ability to continue without interruption.
How Pfizer Used Wearable DHTs To Reveal Meaningful Treatment Effects In Cancer Cachexia
11/20/2024

Wearable digital health technologies (DHTs) played a crucial role in assessing patient-centric outcomes during pfizer's study into the benefits of using ponsegromab for treating cancer cachexia.
Automated Trial Monitoring Workflows Make A Lean Team More Efficient
1/7/2026

A pharmaceutical therapy developer was looking to automate reports, confirmation letters, and follow-up letters. See what happened when they adopted a cloud-based solution for end-to-end trial management.
Solutions To The Challenges Of Oncology Trials
5/6/2025

This significant Phase III trial, one of the largest global studies in head and neck cancer, faced considerable challenges including enrollment delays and an intricate study design.
Meeting 100% Recruitment 7 Months Ahead Of Schedule
7/23/2024

Uncover the detailed outcomes of this extensive Phase 3 clinical trial on a new biosimilar for non-small cell lung cancer.
Boosting Recruitment Strategy For Phase III Study In Ulcerative Colitis
6/10/2025

Learn about the successful execution of a challenging three-arm, randomized, placebo-controlled Phase 3 study in Ulcerative Colitis despite strict inclusion criteria and a limited patient pool.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

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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.

When A Clinical Trial Surfaces In An AI Chat, What Happens Next?

AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.
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.

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.