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White Paper

CAR T Manufacturing and Toxicity

Find out what FDA guidance says about integrating gene delivery vectors, such as CAR T cells, and gene editing technologies (like CRISPR).

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White Paper

sIRB Review for Multicenter Research: A Guide for Institutions

February 15, 2024

Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...

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White Paper

Operationalizing Research Analytics: Today, Tomorrow, Someday

Uncover how analytics, artificial intelligence, and machine learning are reshaping the foundational elements of clinical research.

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White Paper

GxP Compliance in Clinical Research

This white paper walks through key GxP principles and regulatory requirements and gives a real-world case study.

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White Paper

4 Modernized Functions Every Sponsor Needs for Study Startup

This white paper outlines four technology capabilities sponsors need to expedite the study startup process.

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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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White Paper

Data on the go: Mobile Application Considerations for Clinical Trials and Beyond

Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.

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White Paper

Unique First-in-Human Phase I IRB Considerations you Might not Know About

An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.

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White Paper

Understanding how to Build and Leverage a DSMB Statistical Plan

Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.

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White Paper

Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success

Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.

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White Paper

What Does an Endpoint Adjudication Committee (EAC) Do?

This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.

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White Paper

Establishing and Operating a DSMB: Tips for Clinical Trial Success

This white paper shares what a data safety monitoring board's (DSMB's) role is in clinical research and how it works.

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