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Blog

Beginner’s Guide to Medicare Coverage Analysis

Medicare coverage analysis evaluates how clinical research protocol items and services are billed per federal agency guidelines.

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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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Blog

Developing and Implementing a Successful eConsent Process

As the industry continues to shift from brick-and-mortar trials to more convenient hybrid formats, eConsent proves to be useful.

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Blog

Why Now is the Right Time to Adopt eConsent

A valuable tool for both sites and participants, now is the right time for sites to adopt an eConsent platform.

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Webinar

How to Optimize Your sIRB Experience

Upcoming: February 2

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

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Blog

Beginner’s Guide to Budget Negotiation

Proper trial financing ensures internal costs are covered, facilitates better negotiation, and leads to higher compliance in trials.

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Blog

Beginner’s Guide to Single IRB Mandates

More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.

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Blog

Medicare Coverage Analysis Worksheet

Determine whether your trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials.

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Blog

Why Keep HIPAA Separate from the Informed Consent Form

HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.

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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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Blog

Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials

Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.

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Blog

FDA’s September 2022 NPRMs: What They Mean for Academia and Industry

FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.

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