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
Please note that updates to regulations may have been implemented since the publication of this article. The 20th century was the century of many scientific discoveries in the field of medicine....
Clinical Research Solutions
If you work in a regulated industry, you’ve most likely heard the term eQMS or enterprise quality management system. But you may be wondering what is it? Why do I need it? And how do I choose the...
Clinical Research Solutions
A recent survey showed that 33% of the organizations surveyed use paper quality management systems; 60% use some paper and some digital; and 7% use no QMS yet. (source: Gartner peer insights) Quality...
Clinical Research Solutions
The FDA regularly issues new and revised product-specific guidances to facilitate the availability of generic drugs and assist the generic pharmaceutical industry with identifying the most...
Clinical Research Solutions
Everything we do today is traceable. The integrity of the data, documents and decisions needs to be defendable and consistent. Electronic Quality Management Systems (eQMS) are an effective way to...
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...
Regulatory Sciences
Do you really know how to accelerate the approval of your innovative product in Europe? The FDA's incentives for promising new medicines are widely known. Accelerated approval, priority review, fast...
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
Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...
Regulatory Sciences
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...
Medical Information
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...
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...
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...