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
If your only method of quality assurance is software testing, you’re wasting valuable time and resources. Software Quality Assurance (SQA) is integrated into your software development life cycle to...
Clinical Research Solutions
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
Wholesaling is a key factor for drug manufactures and Marketing Authorization Holders (MAH) to ensure supply of pharmaceutical products to their customers at pharmacies and hospitals. Wholesaling of...
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
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
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
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
After assuring clinical validity, finding and managing the right contract manufacturing organizations (CMOs)/contract development manufacturing organizations (CDMOs) is a Sponsor's major concern when...
Clinical Research Solutions
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
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...