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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.
Centralization: Nurturing an Innovative Mindset in Clinical Research
Investing in those who lead your clinical trial associates' (CTAs) is essential to building a thriving clinical research workforce.
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.
Building an Agile Workforce in Clinical Research
While we usually think of our leadership roles as impact roles, it’s time to rethink highly impactful entry-level roles
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.
Clinical Trial Associates and the Future of Pharma
This blog focuses on understanding how the clinical trial associate (CTA) role fits within the clinical research organization.
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.
When Do I Need an EAC?
View this infographic to learn when do you need an endpoint adjudication committee (EAC) and what types of studies an EAC reviews.
The IND Journey Phase I – Navigating Success
Explore strategies for advancing investigational new drug (IND) submissions and a comprehensive guide through Phase I of the IND journey.
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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