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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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White Paper

Planning Organizational Design for Clinical Development Organizations (CDOs)

The white paper outlines key elements for clinical development organizations’ organizational redesign to improve productivity.

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White Paper

Expedite Study Startup: Four Strategies to Optimize Site Activation

Learn how organizations can expedite study startup by streamlining site selection, training, ethics review, and site initiation.

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White Paper

The Rise of the Clinical Research Network: Using Technology to Connect Sites and Sponsors

An integrated approach to the clinical research industry’s technology landscape can improve access and diversity, save time, and better serve patients

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White Paper

Planned Emergency Research and Exception from Informed Consent

This white paper outlines considerations for those involved in planning, designing, conducting or reviewing EFIC studies

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