Reporting Requirements
IRB Review of Virtual Trial Technology
Explore the current regulatory landscape governing mHealth and virtual trial applications in clinical research.
Four Questions to Ask When Establishing a Pharmacovigilance Organization
Four common but critical questions for emerging biotech organizations establishing a pharmacovigilance (PV) organization.
A Checklist for Optimizing Clinical Trial Study Startup Activities
This checklist outlines key milestones and considerations for sites and sponsors in the clinical trial study startup process.
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.
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