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 Clinical Research Solutions

August 2, 2022

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...

Clinical Research Solutions

May 23, 2022

Why Partner with a CRO that has In-House DCT Capabilities?

When you need to outsource your clinical trials and decentralized visits, it can be beneficial to select a single provider that can do both. There are many synergies that come from using a single...

Clinical Research Solutions

April 18, 2022

7 Questions to Ask When Selecting a DCT Provider

When considering a decentralized approach to your clinical trial, it can be confusing or overwhelming to identify a provider that will truly understand and support specific study needs. ProPharma...

Clinical Research Solutions

April 11, 2022

4 Steps to Decentralize Clinical Trials

Decentralized Clinical Trials (DCTs) is a buzzword in the clinical research space that has been gaining notoriety because of the COVID-19 pandemic. It’s a concept that revolves around bringing...

Meet the Expert Clinical Research Solutions

March 21, 2022

Meet the Expert: Shelby Stillwagon

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 Clinical Research Solutions

March 10, 2022

Meet the Expert: Mary Dederich

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

March 2, 2022

Why You Need a Decentralized Clinical Trials Strategy - Before Disaster Strikes

Imagine having your clinical trial ready to go, or already underway, and overnight the brakes are slammed, bringing your trial to a screeching halt. This was the reality for sponsors around the world...

Life Science Consulting Clinical Research Solutions

January 12, 2022

Top Questions & Answers for Managing the New IVDR

With an increased need for high quality in vitro diagnostic medical devices (IVDs), the In Vitro Diagnostic Regulation (IVDR, 2017/746) was entered into force for all IVDs in 2017 with a five-year...

Clinical Research Solutions

December 2, 2021

7 Benefits of Working with a Biostatistician

Biostatisticians have become increasingly important as many data-driven public health projects and clinical trials have expanded. So, what exactly does a biostatistician do? These individuals are...

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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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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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

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