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.

Meet the Expert Program & Project Management

June 19, 2019

Meet the Expert: Abel C. Cortez

ProPharma Group has launched a “Meet the Expert” series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...

Program & Project Management Life Science Consulting

November 15, 2018

The Important Role of Advanced Therapy Medicinal Products

Increasing safe and effective patient treatment opportunities for the future is one of the driving forces behind ProPharma Group’s business. It’s also the driving force behind why many individuals...

ANDA NDA

February 27, 2018

Drug Development: The Key to Success from Concept to Commercialization

Drug Development: The Key to Success from Concept to Commercialization: Congratulations!  You have a lead candidate formulation for your new drug.  You might be thinking to yourself, “okay, now...

Program & Project Management Life Science Consulting

December 18, 2015

Risk-Averse Schedule for Project Management

Is your project schedule ready to pass the Project Management Institute’s (PMI) “litmus test”? Not sure? Well, the Project Management Team at ProPharma Group is here to lend a helping hand. Below are...

Program & Project Management Life Science Consulting

December 9, 2015

Project Bullying

Believe it or not, project bullying in the workplace does exist. It is not a threat only at schools and on playgrounds. Project bullying can come for any source including the Project Manager, the...

Program & Project Management Life Science Consulting

December 1, 2015

Digital Health, Part I: Overview and Introduction

So what’s all the hub-bub about Digital Health? Is it really as big as they say? Is it just a fad? Is it all hype? Well, my answer is yes to all of the above. As with all major new technologies and...

Program & Project Management Life Science Consulting

September 16, 2015

Are You Maximizing Your Return on Data Investment?

Generating process data is expensive:  Costs include materials, process time and the focus of highly-compensated subject matter experts.  Unfortunately, many organizations don’t get their money’s...

Program & Project Management Life Science Consulting

June 30, 2015

If You Didn't Write It Down...

Since the day I entered the industry the mantra of “If you didn’t write it down, it didn’t happen” was repeatedly drilled into my daily mode of operation. The margins of my test sheets were filled...

Program & Project Management Life Science Consulting

June 24, 2015

Sustainable Media Program for the Pharmaceutical Industry, Part II: Tools for Successful Media Fills

Today, ProPharma Group’s Simona Gherman adds to her series on Media Programs and media fills. Part I of this series was an overview with background information and tips. Part II focuses on what you...

Statistical Intervals Confidence Interval Process Validation Life Science Consulting featured-image

Aug 15, 2013 12:00:00 AM

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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General Regulatory Drug Approval Regulatory Sciences featured-image

Mar 29, 2022 12:00:00 AM

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...

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Biostatistics Clinical Research Solutions featured-image

Dec 22, 2020 12:00:00 AM

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...

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ICH MW QC CSR Clinical Research Solutions featured-image

Dec 8, 2020 12:00:00 AM

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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General Regulatory FDA Meetings Regulatory Sciences featured-image

Feb 28, 2017 12:00:00 AM

Formal Meetings Between the FDA & Sponsors or Applicants of PDUFA Products

On March 10, 2015, the FDA published a draft guidance, providing a number of recommendations regarding the conduct of formal meetings between the FDA and Sponsors. These meetings are intended to...

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Regulatory Sciences featured-image

Oct 12, 2022 12:00:00 AM

Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA

For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...

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Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.