Common Pitfalls in Preparing an IND Application
As a drug successfully makes it through the development process, sponsors will inevitably need to submit a new drug application
Consulting
Patient Recruitment and Enrollment in Clinical Trials
For many clinical research staff members, recruiting participants for a study poses a challenge – sometimes a bigger challenge than
4 Questions to Ask When Establishing a Pharmacovigilance Organization
Establishing a compliant pharmacovigilance (PV) function from scratch is often an overwhelming exercise for emerging biotech organizations, typically competing with
A Checklist for Optimizing Clinical Trial Study Startup Activities
From protocol design to site training, optimizing study startup requires meticulous planning and collaboration to ensure timely trial activation.
Best Practices in Pre-Screening Includes Use of Technology
Pre-screening subjects is common practice at most sites. In this article, learn some best practices and how technology can play an important role.
Q&A: Stepwise Implementation of a Clinical Quality Management System
Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. Q: How
Advarra Consulting Delivers Clinical Trial Management Oversight
In this case study, learn how Advarra Consulting, Provided comprehensive clinical quality services, Enabled compliance with good clinical practice requirements, and Assessed and mitigated study startup risks.
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.
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.