Pharmacovigilance
Single Safety Database
March 18, 2024
How to Spring Clean Your PV Safety Data for Optimal Performance
As the blossoms of spring usher in a season of renewal, it's not just our homes that could use a thorough cleaning – our safety data deserves a refreshing sweep too. In an enlightening conversation...
Meet the Expert
Quality & Compliance
March 14, 2024
Meet the Expert: Rodrigo Perez
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Biostatistics
Clinical Research Solutions
March 11, 2024
How Important is Biostatistics?
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
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Clinical Research Solutions
March 7, 2024
Meet the Expert: Michael Church
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
QMS
R&D Technology
March 4, 2024
What are Quality Management Systems (QMS)?
What is Quality Management? Quality Management is the set of processes that enable delivery of high-quality products while maintaining regulatory compliance. Its purpose is to ensure that all...
Quality & Compliance
GxP
February 29, 2024
Understanding GxP Compliance in Drug and Medical Device Development Lifecycle
In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is...
General Regulatory
FDA Meetings
February 26, 2024
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
FDA
Regulatory Sciences
February 26, 2024
The Impact of a US Government Shutdown on the Food and Drug Administration
This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...
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Medical Information
February 22, 2024
Meet the Expert: Eric Brandon
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...