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
Discovering intentional bias in GxP Vendor audits: weighing its advantages, drawbacks, and strategies for effective mitigation. While the prevailing view suggests that GxP auditors should not be...
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
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked 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...
Clinical Research Solutions
On October 3rd, 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend its enforcement approach to Laboratory Developed tests (LDTs). If implemented, this rule would result...
Clinical Research Solutions
The FDA's Breakthrough Devices Program is intended to expedite the development of innovative technologies for patients with life-threatening or irreversibly debilitating diseases or conditions. The...
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
Randomized clinical trials (RCTs) are widely recognized as the gold standard for clinical and regulatory decision-making. Indeed, RCTs would be required in most cases, in particular when modest...
Clinical Research Solutions
Expert Consultant, Regulatory Sciences 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...
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...