Complete Guide to FDA Inspection Readiness
This eBook outlines how to prepare for an upcoming FDA inspection, what to expect during the inspection, and steps to take following inspection close.
Consulting
Centralization: Nurturing an Innovative Mindset in Clinical Research
Did you know 70% of the variance in team engagement is attributed to an employee’s direct manager? This means the
Large Research Healthcare System Maintains Compliance through Internal Program Assessment
Download the case study to learn how Advarra’s Institutional Research CoE helped ensure compliance and maintained critical funding sources.
Large Clinical Research Site Network Streamlines Study Startup with Reliable, Timely ICF Writing Services
Discover how Advarra’s ICF writing services helped a site network create compliant, flexible processes, improving IRB submissions and timelines.
The IND Journey Phase I – Navigating Success
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Building an Agile Workforce in Clinical Research
Most organizations understand the importance of creating a competitive advantage with a targeted, aggressive hiring strategy – but why is
Beginner’s Guide to Pre-IND Meetings
New to the process of helping to bring a drug to market? As intimidating as the Food and Drug Administration
Clinical Trial Associates and the Future of Pharma
Now more than ever, there is enormous pressure to deliver products to the market faster and cheaper. In the clinical
What do I do About Incidental Findings in Research?
An incidental finding is a “finding” or result from an intervention or test that uncovers a condition or problem that
Clinical Trial Superheroes
Explore the contributions of clinical trial superheroes, from coordinators to data analysts, improving patient health and outcomes.
Planning Organizational Design for Clinical Development Organizations (CDOs)
Discover how CDOs can balance productivity and quality by exploring agile approaches, benchmarking insights, and key elements of organizational redesign.
5 Considerations for Evaluating an eIRB System
In addition to other responsibilities, human subjects protection programs (HRPPs) and IRBs are tasked with ensuring a research protocol’s lifecycle