Newsletter | September 18, 2025

09.18.25 -- 2 Ways To Overcome The Challenge Of Developing Neurological Rare Diseases Drugs

SPONSOR

Webinar: Ensuring Compliance in Gene Therapy Trials for Neurological Disorders: IRB and IBC Perspectives

Gene therapy research for neurologic disorders presents distinct ethical, regulatory, and biosafety challenges, particularly with vulnerable populations. In this BRANY webinar, IRB and IBC experts, along with a medical ethicist and neurologist, share insights on nuanced consent, caregiver considerations, and oversight. Sponsors, CROs, investigators, and review boards will gain guidance to navigate these complex trials. Click here to learn more.

REGULATORY & COMPLIANCE

2 Ways To Overcome The Challenge Of Developing Neurological Rare Diseases Drugs

GRIN Therapeutics CEO Bruce Leuchter, MD, explores how integrating new business models and technological advances will be crucial to developing new treatments for rare neurological disorders.

Managing Risk And Regulation In Clinical Trial Technology

Now is the time to evaluate your current risk management framework. Take action today to strengthen your safeguards, tailor your risk assessments, and prioritize transparent patient engagement.

Comply With The New NIH Transparency Rules For r/sNA Molecule Research

Review new transparency requirements for NIH-funded institutions engaged in research involving r/sNA molecules and regulations for Institutional Biosafety Committees (IBCs).

Navigating Regulatory And Privacy Updates In Clinical Trials

Explore how the guide for eRegulatory adoption in Canada provides resources to help stakeholders navigate these changes and enhance participant engagement and retention in clinical trials.

Five Ways To Get Ready For IRT Regulatory Inspections

Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

SPONSOR

Join our expert panel on Clinical Leader Live on September 26 at 1pm ET as we explore the urgent need for diversity in clinical trials amid political headwinds and policy rollbacks. We’ll unpack recent setbacks, examine their real-world impact, and discuss why equitable patient recruitment must remain a top priority. Don’t miss this timely conversation on safeguarding inclusion in medical research. Registration is free. Reserve your spot today.

OUTSOURCING MODELS

What The Heck Are Financial Accruals? A Guide To Understanding The Mysterious Finance Brain

Clinical finance consultant Chris Chan helps clinical professionals understand financial accruals concepts and interpret requests from finance colleagues.

Dispelling Common Clinical Trial Oversight Myths

Many clinical trial oversight problems can be avoided or mitigated by sponsor understanding root causes and being a proactive collaborator with its partners.

Cold Chain Logistics And Packaging Considerations For Probiotics

Choosing the right packaging partner for your probiotic may be the most crucial step to ensuring your product is safe and potent when it reaches the consumer.

Improving ISR Success Rates In Bioanalysis Of Small Molecule Drugs

Leveraging incurred sample reanalysis (ISR) in your quality control helps your team mitigate risks, establish regulatory compliance, and instill confidence in your pharmacokinetic modeling.

How To Build Partnerships For Sustainable Healthcare

Effective partnerships are essential to address the multifaceted challenges of the healthcare sector, yet collaborative efforts often face persistent barriers.

A Streamlined Approach To 14C Human ADME Studies

Understand the benefits of a program that allows for a flexible approach to human ADME studies and the breadth of supporting data and case studies that demonstrate both significant time and cost savings.

FSP: Global Support To Fit Clinical Trial Management Needs

Catalyst Flex provides flexible, scalable solutions and services to enhance our clients’ outsourcing needs. We are a specialized provider of multi-therapeutic functional solutions delivered by our experts.

PCI Pharma Services Capacity Update July 2025: Fill/Finish

PCI is positioned to meet the future of sterile pharmaceutical development and manufacturing with cutting-edge technology, and innovative solutions for high-value biologics, complex formulations, and lyophilized drug products.

Easy-to-Use Analytics Platform For Vendor Selection And Management

ClinAI helps you centralize RFPs, budgets, and vendor data—so you can select the right partners, manage change orders, and keep your studies on track.

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You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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