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.

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

Roadmap for Successful IVDR Transition, Part III: Project Management

The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching in May 2022. In this blog series, we discuss the final months before the IVDR date of application, how to...

Clinical Research Solutions

Do You Know Your Quality Score?

We live in a world of measurement and metrics. Running a successful business requires a thorough analysis on the work, sales, and financial results. Of course, identifying and tracking business...

Clinical Research Solutions

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

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...

Clinical Research Solutions

What the IVDR Is and How to Prepare

In May 2022, the IVDD will be repealed by the European Committee, thereby ending the transition period. To ensure you're compliant with IVDR by that date, learn everything you need to know about the...

Clinical Research Solutions

Battle of the Regulators: Comparing FDA’s Accelerated Approval and EMA’s Conditional Marketing Authorisation

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer various pathways that can expedite the development and review of new therapies to treat serious or...

Clinical Research Solutions

Roadmap for Successful IVDR Transition, Part II: Technical Documentation & Software

The compliance dates for the In Vitro Diagnostics Regulation (IVDR) are quickly approaching (May 2022). In this blog series, we discuss the final months before the IVDR date of application along with...

Clinical Research Solutions

CMC Regulatory Dossier Compliance: A GMP Requirement

Maintaining compliance in the dynamic regulatory Chemistry, Manufacturing and Controls (CMC field can be quite a challenge. A CMC regulatory dossier compliance assessment is a critical component and...

Clinical Research Solutions

Meet the Expert: Marshall Scicchitano

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...

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...

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...

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...

Prev 24 25 26 27 28