Clinical Research Solutions
Post-COVID Challenges with Investigation Backlog: Are You Ready for the Inevitable?
In early 2020, while COVID-19 was wreaking havoc on public health and safety, the FDA took the unprecedented step of postponing domestic and foreign inspections. The FDA’s risk-based inspection...
Clinical Research Solutions
Meet the Expert: Carrie Rabe
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
Checklist for Building a Successful Risk Evaluation and Mitigation Strategy (REMS) Program
A Risk Evaluation and Mitigation Strategy (REMS) is a risk management program that serves to inform and educate patients and health care providers about the serious risks of a drug and offer tools...
Clinical Research Solutions
Meet the Expert: Gary Hyde
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
The Anniversary We Didn’t Want: One Year of COVID-19 Milestones
On March 11, 2020, after months of researching, strategizing, and meeting with various leaders and medical experts globally, the World Health Organization (WHO) declared COVID-19 to be a global...
Clinical Research Solutions
Project Management and a Successful Reduction in Investigations Backlog: The Beauty and the Beast
Many of us have been faced with this beast that needs taming: a regulatory agency has conducted an inspection of your facility. Their observation is that the backlog of investigations at your site is...
Clinical Research Solutions
Understanding FDA Pre-ANDA Meetings
Brought into being by the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II), the FDA’s pre-ANDA program is designed to accelerate access to generic versions of complex products. The...
Clinical Research Solutions
Biomanufacturing World Summit
The Biomanufacturing World Summit brings together the “who’s who” of pharmaceutical executives and cutting-edge technology providers for North America’s premier biologics event. Make plans to attend,...
Clinical Research Solutions
How to Manage the Risk of Elemental Impurities with ICH Q3D
How to Manage the Risk of Elemental Impurities with ICH Q3D: The mission of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is to ensure...
Clinical Research Solutions
What It Takes to Be Successful with GDUFA in 2021
GDUFA II was signed into law in 2017 effectively reauthorizing GDUFA I for fiscal years 2018 through 2022. The continuing goal of the amendment is to facilitate timely access to high-quality,...