Clinical Research Solutions
Meet the Expert: Markus Ganzlin
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...
Clinical Research Solutions
FDA Proposes New Rule for Distribution Compliance
FDA has announced the availability of a proposed rule National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs). The proposed rule sets...
Clinical Research Solutions
Autism Awareness: Advancing Early Diagnosis in Children
Did you know that 1 in 44 American children is autistic, and approximately 5.4 million adults in the U.S. are autistic as well? It's an extraordinarily diverse group too, as autism spectrum disorder...
Clinical Research Solutions
Annex 21: What You Need to Know
It’s finally here, a guidance on how to handle medicinal products imported from outside EU/EEA. If you’ve ever wondered what the expectations are on these imported medicinal products, you’re in for a...
Clinical Research Solutions
Meet the Expert: Jeff Block
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...
Clinical Research Solutions
Meet the Expert: Raphael Richarz
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...
Clinical Research Solutions
Meet the Expert: James Meckstroth
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...
Clinical Research Solutions
Roadmap for Successful IVDR Transition, Part III: Project Management
The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching in May 2022. In this blog series, we discuss the final months before the IVDR date of application, how to...
Clinical Research Solutions
Do You Know Your Quality Score?
We live in a world of measurement and metrics. Running a successful business requires a thorough analysis on the work, sales, and financial results. Of course, identifying and tracking business...
Clinical Research Solutions
What the IVDR Is and How to Prepare
In May 2022, the IVDD will be repealed by the European Committee, thereby ending the transition period. To ensure you're compliant with IVDR by that date, learn everything you need to know about the...