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White Paper

Navigating Key Complexities in the Development of Cell and Gene Therapies

Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.

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Webinar

FDA/OHRP Harmonization and Your HRPP Operations

Upcoming: June 15

This webinar will discuss the human research protection program (HRPP) opportunities and challenges through FDA and OHRP harmonization.

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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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5 min. read
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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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5 min. read
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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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4 min. read
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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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3 min. read
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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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Webinar

Is Your Site Ready for an FDA Inspection?

Understand the FDA’s expectations for a site inspection, GCP compliance, and maintaining study integrity.

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E-Book

Trend Report: 2023 Trends Impacting Clinical Research

This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.

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Webinar

How to Optimize Your sIRB Experience

Find out how other institutions have used sIRB requirements as an opportunity to elevate their research programs in this webinar.

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Webinar

Rare and Orphan Diseases in Regulated Development

In this webinar, gain an in-depth understanding of regulatory and clinical development challenges for rare/orphan diseases.

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Abstract

Simple Strategies for Identifying Research Compliance Blind Spots

David Staley authored the article Simple Strategies for Identifying Research Compliance Blind Spots in Compliance Today.

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