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Clinical Research / Monitoring

Navigating Change in Biopharmaceutical Development: The Crucial Role of Change Management

In today's dynamic biopharmaceutical industry, change is not merely a constant; it's an imperative. The pace of innovation, evolving regulatory requirements, and shifting market demands...

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Clinical Research / Monitoring Medical Writing

Connecting the Dots: How Medical Writers Interpret, Analyze, and Apply Key Lessons From the Latest FDA Guidances to Clinical Studies

In the dynamic world of biopharmaceutical development and manufacturing, the advent of gene editing and CAR-T therapy represents a monumental leap forward in medical innovation. However,...

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Safety

Best Practices for Developing Safety Profiles in Rare Disease Clinical Trials

In developing drugs for rare diseases, ensuring long-term patient safety is paramount. Unlike more common conditions, rare diseases present unique challenges that make creating a...

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Clinical Research / Monitoring Technology Insights

Optimizing Clinical Trial Supply Management: Harnessing AI for Efficiency and Sustainability

The production of investigational products (IPs) for clinical trials stands as one of the most financially burdensome tasks for biopharmaceutical companies of all sizes. The intricacies of...

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Clinical Staffing Talent/Career Tips

Welcoming New Talent: Inside the ACCEL Program for Clinical Research Careers

Q&A with Allison Spain, Former ACCEL Associate Entering the clinical research industry—whether you are an early career professional or looking to make a mid-career shift—can seem daunting....

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Therapeutic Insights

Breaking Barriers: Advances and Challenges in Therapeutic Cancer Vaccines

Imagine a world where we can arm the body's defenses, pre-emptively training the immune system to unleash a formidable army of tumor-fighting cells. While preventive vaccines have triumphed...

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