An Evolving Regulatory Environment for Rare and Orphan Diseases
Rare diseases affect fewer than 200,000 people each, totaling around 30 million in the U.S. Orphan drugs face R&D barriers, but FDA support has increased since 1983.
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Q&A: FDA Updates: BIMO – What Sponsors Need to Know
Advarra experts Joan Versaggi and Leslie Paul answer questions from the first in the webinar series – FDA Updates: BIMO
Understanding International Data Transfer’s Impact
The landscape of data privacy is certainly dynamic and, at times, imposing. In particular, transferring data across borders can be difficult to navigate.
Data Integrity – It’s All About the Data!
In this increasingly digital world, we have to remember data is now available in many different medians, including paper. When we think of clinical trials and the critical data
Why it is Critical to Have and Enforce a Data Strategy?
The Call to Action Data is the most important asset for a pharmaceutical or biotechnology company to produce during clinical
Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug
A Tale of Two Sites: The Power of Integrated Research Administration
Site timelines for studies can vary widely across the industry due to differences in internal efficiency. In this blog, James Riddle (Advarra VP of Institutional Services and Strategic Consulting) tells the tale of two sites, one with an integrated research administration, and one without.