thought leadership

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.

Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights

As a rapidly expanding market, the Japan and Asia-Pacific (JAPAC) region presents a unique and complex landscape for those who are looking to establish a medical information (MI) function. Having a robust and compliant MI function is crucial to the success of the product lifecycle and demonstrates...

Meet the Expert: Beverly Zhuge

Clinical Research Solutions

Meet the Expert: Beverly Zhuge

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...

Meet the Expert: Robbie Rachford

Clinical Research Solutions

Meet the Expert: Robert Rachford

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...

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Pharmacovigilance

How to Spring Clean Your PV Safety Data for Optimal Performance

As the blossoms of spring usher in a season of renewal, it's not just our homes that could use a thorough cleaning – our safety data deserves a refreshing sweep too. In an enlightening conversation...

Meet the Expert: Rodrigo Perez

Clinical Research Solutions

Meet the Expert: Rodrigo Perez

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...

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Clinical Research Solutions

How Important is Biostatistics?

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...

Meet the Expert: Michael Church

Clinical Research Solutions

Meet the Expert: Michael Church

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...

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Clinical Research Solutions

What are Quality Management Systems (QMS)?

What is Quality Management? Quality Management is the set of processes that enable delivery of high-quality products while maintaining regulatory compliance. Its purpose is to ensure that all...

People working at a table with medical and computer devices

Clinical Research Solutions

Understanding GxP Compliance in Drug and Medical Device Development Lifecycle

In the complex world of drugs and medical devices, where every pill, syringe, and implant holds the potential to impact lives profoundly, ensuring the utmost safety, efficacy, and quality is...

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Regulatory Sciences

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

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

Understanding Statistical Intervals: Part 2 - Prediction Intervals

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...

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Clinical Research Solutions

FDA’s Expedited Programs Explained

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

A Guide to the Clinical Study Report

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...

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Medical Information

What are Patient Support Programs?

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...

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Clinical Research Solutions

How Important is Biostatistics?

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...

Casually dressed business professionals discussing intensely at a conference table

Regulatory Sciences

Formal FDA Meetings for Sponsors or Applications of PDUFA Products

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...

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