Reporting Requirements
Common Elements of IRB Assessments
Like other IRBs, Advarra is subject to inspections from time to time. What standards are we measured against?
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.
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.
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.
The ROI of eRegulatory and eIRB Integration
Learn about the benefits to integrating with technology systems such as email, eIRB, CTMS, and other eReg platforms as you increase ROI.
The Whole Product Approach
Learn how your organization can implement the Whole Product Approach and how Advarra uses this method to help research sites.
Large Clinical Research Site Network Streamlines Study Startup with Reliable, Timely ICF Writing Services
Advarra improved startup timelines by writing compliant informed consent forms (ICFs) for a large clinical research site network.
A Holistic Approach to Ensuring Success with Your Technology Systems
In this webinar, we outline the Whole Product Approach, a comprehensive strategy focusing on all aspects of the user and site experience.
Beginner’s Guide to Pre-IND Meetings
This blog provides a beginner’s overview of what the pre-IND meeting is and how to prepare for one.
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.
What do I do About Incidental Findings in Research?
Each incidental finding has an impact on how research professionals handle the result and whether it should be shared with participants.
What Goes into a Charter for DSMB or Endpoint Adjudication?
This blog outlines the key elements of a DMC/EAC charter document, explaining its importance in conducting safe and compliant research.
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