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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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White Paper

Ensuring Success with Clinical Development Planning

This white paper describes how to ensure a clinical plan’s feasibility, focusing on issues that matter, and mitigates anticipated program risk.

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White Paper

Executing a Successful Clinical Strategy

A clinical development plan is designed to bring an investigational medicinal product to market through outlining risks and opportunities to a program.

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White Paper

Reporting to the IRB: What Does and Does Not Need to be Reported

This white paper outlines IRB reporting requirements, why reporting is important, and what should and should not be reported.

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White Paper

The ROI of Site-Centric Training and Support

Download our white paper to learn how to maximize your research investment for site-centric training and support.

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White Paper

Enabling Compliant Remote Data Capture and Document Management

Download this white paper to learn how to establish consistent electronic processes to help manage clinical trials remotely.

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