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Blog

What Sponsors Need to Know About Medicare Coverage Analysis

Discover the role of MCA in clinical research, its impact on study activation timelines, and how outsourcing can streamline trials.

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Blog

Collaborating with Research Sites: Best Practices for Site Selection and Study Startup

Key strategies for successful research study startup: site selection, documentation, and effective initiation.

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Blog

Key Efficiencies Driven by a Clinical Trial Management System

Find out how sites can get the most value from their clinical trial management system (CTMS) to streamline operations.

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Blog

Improving Diversity in Clinical Trials: Strategies for Inclusive and Ethical Research

Learn practical strategies on how to improve diversity in clinical trials for historically under-represented groups.

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Blog

Beginner’s Guide to IRB Review of IVD Research

If an investigational in vitro diagnostic (IVD) device is used in clinical research, it may require IRB review.

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Blog

Patient Recruitment from a Site Perspective: Technology Meeting Today’s Challenges

Discover how CTMS streamlines patient recruitment & management for successful clinical trials.

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Blog

Risk Assessment for use of Engineered Genetic Materials in Clinical Research

Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.

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Blog

How Single IRB Review Mandates Help Research Sponsors

The proposed single IRB mandates will impact FDA-regulated research, potentially altering existing practices at organizations.

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Blog

Top 3 Reasons Why Your Medical Device Needs a Clinical Trial

Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.

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Blog

FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy

FDA recently released new guidance, potentially impacting early-phase cell and gene therapy trials.

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Blog

eReg Benefits for Clinical Research: Use Cases for all Types of Sites

Using an eRegulatory system can benefit any site, helping to increase productivity, improve compliance, and save money.

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Blog

Sickle Cell Disease: The Importance of Amplifying Patient Voices

Sickle cell disease significantly impacts the African American population, a minority community historically underserved by clinical research.

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6 min. read
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