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.

Vigilance by Another Name

Do regulations and guidance documents sometimes stagnate your learning progress because of the terminology used? Regulation confusion is a common complaint heard from current and prospective new clients. To understand which rules apply in each situation, and to which parties, we have to first start...

Two women collaborating in a laboratory working on a laptop computer.

R&D Technology

Leveraging Veeva Vault’s TMF Bot & AI to Improve Quality and Consistency

The Trial Master File (TMF) allows an effective way to collect and manage study specific documents during a clinical trial. The TMF serves as a complete and accurate record of the trial's conduct,...

A patient receiving an injection from a nurse.

Clinical Research Solutions

Why Decentralized Clinical Trials are the Future of Clinical Research

Decentralized clinical trials (DCTs) have emerged as a transformative approach in clinical research, offering unique benefits that challenge the traditional models. However, deciding whether to...

Meet the Expert: Jens van Wijngaarden

Clinical Research Solutions

Meet the Expert: Jens van Wijngaarden

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...

Decentralized clinical trial nurse injects a patient with a syringe.

Clinical Research Solutions

Benefits of Decentralized Clinical Trials

In recent years, the landscape of clinical trials has undergone a remarkable transformation with the emergence of decentralized clinical trials (DCTs). These innovative approaches leverage technology...

Meet the Expert: Warren Vieira

Clinical Research Solutions

Meet the Expert: Warren Vieira

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...

Medical information and data displayed on a tablet device.

Medical Information

Artificial Intelligence in the Medical Information Industry: Transforming Healthcare with AI and Automation

The rapid advancement of artificial intelligence (AI) technology has revolutionized various industries, including the medical information sector. One notable AI-driven tool is ChatGPT, developed by...

Meet Ioana Panturoiu, Senior Manager, PV Alliance Management

Clinical Research Solutions

Meet the Expert: Ioana Panturoiu

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...

Kimberly Futch - Director, Clinical Operations Strategy

Clinical Research Solutions

Meet the Expert: Kimberly Futch

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...

Pins located on Australia on a globe.

Clinical Research Solutions

Clinical Trials in Australia: Unlocking Value for Clients

In recent years, Australia has emerged as a leading destination for conducting clinical trials, attracting pharmaceutical, biotech, medical device/diagnostic companies, and research organizations...

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...

Hands working on a laptop.

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...

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...

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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