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.

Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions

For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program. These early interactions help Sponsors validate regulatory assumptions, align on data requirements,...

Clinical Research Solutions

Top Tips for a Successful Virtual Audit

The COVID-19 pandemic forced countless companies to change the way they do business in order to continue operating while protecting employees and upholding their social responsibility to the...

Man reviewing an overlay of graphs, data, and maps

Clinical Research Solutions

An Introduction to Scientific Data Standards

With automation becoming more mainstream in science, vast quantities of data are now generated by many organizations every day. This deluge of data is often managed ineffectively, limiting the...

Clinical Research Solutions

COVID-19 Pandemic in the EU: Fraudulent Medicines, Test Kit Shortage, & EMA Guidance Regarding Ongoing Clinical Trials

As of March 27, 2020 Each health authority within the EU has information regarding COVID-19 (coronavirus) on its website. In this blog we will try to guide you through some of these recommendations...

Clinical Research Solutions

5 Scenarios That Need a Clinical Operations Team

New drug development is a costly, lengthy and risky process. Hurdles spring up at every stage and today's landscape puts sponsors under more pressure than ever before. Clinical trials are becoming...

Clinical Research Solutions

Ten Tips for Conducting Successful Virtual FDA Meetings in the Era of COVID-19

The outbreak of COVID-19 (coronavirus) in the United States has significantly impacted our lives in virtually every way. For pharmaceutical and medical device firms, one of these impacts came on...

Clinical Research Solutions

Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part II

Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will continue to guide you through all these recommendations and...

Clinical Research Solutions

Health Authorities’ Information on the COVID-19 Pandemic Throughout Europe, Part I

Each EU Health Authority has published a wide range of information regarding coronavirus, COVID-19, on their websites. In this blog we will try to guide you through all these recommendations and...

Clinical Research Solutions

Do You Need a Project Management Office (PMO)?

There is more to a project management office than managing projects. In fact, the project management office (PMO) acts as both a watchtower and a lighthouse to guide strategic initiatives toward...

Clinical Research Solutions

Embracing Risk Management Principles: As Easy as One, Two, Three

In the pharmaceutical industry today, there are strict guidelines to adhere to throughout the product lifecycle. Some of them, like risk management, seem more complex and harder to adhere to than...

Clinical Research Solutions

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...

Healthcare worker showing a woman details on a tablet device.

Clinical Research Solutions

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...

Casually dressed business professionals discussing intensely at a conference table

Clinical Research Solutions

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

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...

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...

Prev 45 46 47 48 49