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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

RWD, New Technologies Show Potential In Clinical Trial Recruitment
Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.

What Clinical Trial Decision Makers Are Prioritizing In 2025
5/7/2025

In 2025, clinical trial operations are undergoing a transformative shift driven by the need for speed, cost-efficiency, and patient-centered approaches.
Hospital-Based eCOA Implementation: Real Challenges In Infectious Disease Trials
11/21/2025

This resource outlines proven strategies to reduce delays, improve compliance, and meet regulatory standards for PRO data in infectious disease studies.
Open-Label Study Assessing Relative And Absolute Bioavailability
1/26/2026

Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.
Tracking Functional Capacity To Advance Neuromuscular Disease Research
2/6/2026

This presentation introduces a dual-endpoint approach to monitoring neuromuscular disease progression through two high-centile digital measures.
ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations
11/21/2025

Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

Driving A High-Adherence LTFU Trial Without An EDC
10/29/2025

Discover how our partnership with a client was able to deliver a ten-year long-term follow-up (LTFU) trial that delivered an over 90% adherence rate while keeping trial costs low by not using an EDC.
Using Virtual Study Coordinators For EDC Entry And Query Resolution To Speed Up Data Access And Cleaning
1/31/2025

The piece showcases how the effective use of CRIO can significantly enhance site performance, supporting recruitment and diversity objectives for sponsors.
Early-Stage Development In Rare Pediatric Oncology
4/11/2025

Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.
Expanding Clinical Research In East Africa With Digital Innovation
12/11/2025

Africa carries 25% of the world’s disease burden but hosts only 1% of clinical trials. Discover technology-driven strategies that close this gap and transform research access in underserved regions.
How To Unlock The Secret To Repeatable, Scalable Low Turnover
6/7/2024

Here, we explore the evolution of a 10-year partnership and extrapolate the principles that create cohesive teams and minimize turnover.
Suvoda Products
9/5/2025

Suvoda Products Listing.

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.

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.