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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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Blog

Regulatory Trends in Cell and Gene Therapies

Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.

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6 min. read
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E-Book

Setting Yourself up for Success During Investigator-initiated Trials

This eBook shares tips and best practices to guide researchers through the investigator-initiated trial process while staying compliant.

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Webinar

Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software

Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.

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Webinar

Inspection Readiness: Before. During. After

This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.

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Blog

How the IND 30-day Hold Impacts Clinical Trial Activities

Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.

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6 min. read
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Webinar

A Guide for Successful Cell and Gene Therapy Research

Understand the unique regulatory, clinical, and manufacturing requirements for cell and gene therapy research.

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