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
The COVID-19 pandemic revealed a structural weakness in many products’ supply chains. In terms of supply of pharmaceutical products, supply shocks were not mitigated when intermediates or production...
Clinical Research Solutions
Today, with the FDA endorsing fewer new treatments, life sciences companies are pressured to develop better therapies while also struggling to control costs and retain their star employees. And while...
Clinical Research Solutions
When conducting a clinical trial, there are many aspects sponsors need to be aware of with regards to clinical safety, product efficacy, and the ability to bring treatments through the multiple...
Clinical Research Solutions
On Friday, June 19th, the FDA issued a guidance document explaining what manufacturers of drugs and biological products should do, if and when, employees become infected with COVID-19. The...
Clinical Research Solutions
The submission of your drug application (NDA, ANDA, BLA, etc.) is an exciting accomplishment, and one of the first major milestones is a pre-approval inspection (PAI) of the manufacturing sites...
Clinical Research Solutions
The benefit-risk assessment is the cornerstone of how all drugs are approved. This assessment captures the scientific evidence, uncertainties, policy, and reasoning used by FDA officials to arrive at...
Clinical Research Solutions
Did you miss our last blog on PAI Readiness? Catch up here to learn what a PAI is and how to prepare. Congratulations! You conducted a Mock Inspection in preparation for your upcoming Pre-Approval...
Clinical Research Solutions
Combination products represent an important and growing category of therapeutic and diagnostic products. They come in several configurations and can be composed of any combination of a drug and a...
Clinical Research Solutions
In the latest PMI report Pulse of the Profession 2020 (2020), 11.4% of surveyed organizations attribute investment waste to poor project performance. What defines project performance and ultimately...
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...
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
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...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
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...
Regulatory Sciences
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...