ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Clinical Research Solutions
FDA has issued the final guidance titled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The recommendations for prescription drug and...
Clinical Research Solutions
The FDA’s Office of Clinical Pharmacology within the Office of Translational Sciences released a new draft guidance document that, for the first time, clearly addresses the FDA’s recommendations and...
Clinical Research Solutions
Guidance for Industry May 2022 Today, FDA is announcing revisions to the 2006 guidance “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.” Specifically, this...
Clinical Research Solutions
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
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
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
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
When considering a decentralized approach to your clinical trial, it can be confusing or overwhelming to identify a provider that will truly understand and support specific study needs. ProPharma...
Clinical Research Solutions
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
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Clinical Research Solutions
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...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...