Newsletter | March 28, 2025

03.28.25 -- Is The BIOSECURE Act The First Real Step Toward Reshoring?

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Webinar: Critical Imaging Risks in GLP-1 and Neurology Studies: What You Need to Know

Clinical trials in GLP-1 and neurology rely increasingly on imaging, but challenges often go unaddressed. This webinar covers early indicators of imaging issues, preclinical insights, expanding imaging requirements, and hidden risks. Attendees will learn how early identification of imaging risks, preclinical data, and strategic planning can mitigate delays, improve trial efficiency, and ensure regulatory compliance. Click here to learn more.

FOCUS ON SUPPLY CHAIN

Is The BIOSECURE Act The First Real Step Toward Reshoring?

The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?

"Bestcellers": Controlled Filling And Freezing Of Cells

Learn how state-of-the-art technologies provide control over the freeze-thaw process fostering drug discovery and development, thus facilitating commercial production of novel treatments.

SUPPLY CHAIN SOLUTIONS

50-ML Stability Container Assembly For Frozen Storage - W.L. Gore & Associates

FOCUS ON CLINICAL TRIALS

Transforming Neurodegenerative Disease Research With iPSCs: A Path To Innovation And Therapeutic Breakthroughs

This article details why iPSC-based therapies offer promising yet experimental solutions for neurological disorders with early clinical studies demonstrating safety and potential efficacy, though long-term outcomes remain to be validated.

Overview Of Triple-Negative Breast Cancer: Global Clinical Trial Landscape

Triple-Negative Breast Cancer (TNBC) requires new and innovative treatments, such as biomarker-driven therapies, to enhance precision medicine and improve patient outcomes.

Successful Regulatory Submission Via The Trifecta Of Awesomeness

Three essential elements contribute to a repeatable, adaptable regulatory submission process: strategic planning, team engagement, and properly leveraging team experience.

How To Build A Hybrid Visit Strategy That Delivers High-Quality Results

In-home clinical trial visits yield major benefits for patients, including increased access and convenience. As a result, hybrid trials are helping developers increase enrollment, engagement, and retention.

Weighing The Suitability Of An FSP Model For Clinical Trials

Learn more about what a Functional Service Provider (FSP) is, and review key points to consider when deciding if a functional service approach could better serve a clinical team and its study.

5 Ways Lab Data Can Help Commercialize Your Therapy

Explore five key insights into how our de-identified diagnostic lab data can be leveraged to maximize the success of new therapies in the market.

Why Mobile Eye Exams Are Critical In Clinical Trials With Ocular Endpoints

Many clinical sites lack necessary ophthalmic resources for eye exams. Mobile services can address these issues while improving patient retention through minimizing travel and appointment disruptions.

CLINICAL TRIALS SOLUTIONS

Reviewing Protocols Across Therapeutic Areas - BRANY

Get The Right Participants For Your Study Easier And Faster - OpenClinica

Unlocking Healthier Futures With Cell And Gene Therapy - Cencora

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