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Blog

Beginner’s Guide to eTMF, eISF, and Regulatory Research Documents

Global & FDA regulations dictate how researchers organize & store trial documents. Learn the basics of eTMF & eISF clinical research tools

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5 min. read
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Case Study

Developing an Enterprise Roadmap to Post Authorization Safety Studies

Learn how an organization achieved organization-wide compliance and managed its post-authorization safety studies.

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Blog

Expanding the Ecosystem to Better Serve You

June 30, 2022

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Blog

Common Pitfalls in Preparing an IND Application

While the IND application process may be straightforward to some, we explore the most common pitfalls as sponsors prepare for submission.

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6 min. read
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Webinar

IRB Review of Decentralized Trial Technology

Explore the current regulatory landscape governing mHealth and virtual trial applications in clinical research.

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Blog

Common Elements of IRB Assessments

Like other IRBs, Advarra is subject to inspections from time to time. What standards are we measured against?

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5 min. read
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Blog

Why do Funding and Legal Structure Matter in Decentralized Clinical Trials?

Both sites and sponsors must consider how DCT funding and legal structures can impact sites and the study itself.

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3 min. read
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Blog

Q&A: Stepwise Implementation of a Clinical Quality Management System

Advarra expert Steffen Engel answers questions from the webinar, Stepwise Implementation of a Clinical Quality Management System.

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8 min. read
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Case Study

Advarra Consulting Delivers Clinical Trial Management Oversight

Download this case study to learn how Advarra Consulting mitigated risks and enabled compliance for a medical device organization.

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E-Book

Complete Guide to FDA Inspection Readiness

Learn how to prepare for an upcoming FDA inspection, what to expect during the inspection, and steps to take following inspection close.

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Info Sheet

Research Billing Services Info Sheet

Advarra's research billing services can ensure proper research billing compliance, administration, and operations.

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E-Book

The Whole Product Approach

Learn how your organization can implement the Whole Product Approach and how Advarra uses this method to help research sites.

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