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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...

Clinical Research Solutions

5 Step Plan for Data Integrity Compliance

Are you always ready to be inspected for Data Integrity (DI) activities in your facility? Are compliance and data integrity aspects implemented in your organization’s QMS? Are the systems in your GxP...

Clinical Research Solutions

Five Steps Toward a Mature Data Integrity Culture

The corporate and quality culture has a significant effect on the maturity level of Data Integrity within a regulated company and should, therefore, be assessed and understood. To achieve the level...

Clinical Research Solutions

How to Present Scientific Data That Generates Regulatory Approvals

Today’s patients benefit from having access to the safest, most advanced pharmaceutical systems around the world. This is because of the work done by the various regulatory bodies who govern the...

Clinical Research Solutions

Meet the Expert: Hanna Edling

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

Have an FDA Submission on Your 2021 To-Do List?

At the start of every year, we all have these grand plans of everything we plan to accomplish. It is a fresh start to really get stuff done and we have a full 12 months to do it all. However,...

Clinical Research Solutions

Meet the Expert: Bram Lardée

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

How to Implement an Effective Audit Trail

Maintaining an audit trail is a regulatory compliance requirement, but what makes an audit trail beneficial for maintaining effectiveness and complying with regulations? This blog will explain what...

Clinical Research Solutions

Prepare for Your Next Audit: A 5-Point GMP Checklist

Ensuring you have full control over your processes, facility, and quality management system (QMS), and ultimately your final product quality, is a demanding and important task. An inability to do so...

Clinical Research Solutions

Meet the Expert: Bob Verhoeff

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

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

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...

Regulatory Sciences

What to Expect During the NDA Review Process

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...

Healthcare worker showing a woman details on a tablet device.

Medical Information

What are Patient Support Programs?

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...

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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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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