Quality & Compliance
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...
Clinical Research Solutions
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 worth...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
Sustainable Media Program for the Pharmaceutical Industry, Part I: Simple and Straightforward Information and Tips
Would your media program pass the test? The FDA inspection test, that is. In this new blog series, ProPharma Group’s Simona Gherman breaks down the FDA regulatory requirements for a successful media...
Clinical Research Solutions
PMP: The Benefit of Quality Knowledge
There are thousands of drug manufacturers that have a number of ongoing projects within Operations. Often times, these companies seek experienced consultants to assist/guide them to project...
Clinical Research Solutions
The Use of a Target Product Profile Early in Drug Development - A Great Program Management Tool
Let’s face it, drug development is a very long process. It is often hard for scientists in a laboratory to picture their drug actually being manufactured at large scale let alone to imagine it in a...
Clinical Research Solutions
Project Management - 100% Responsibility and 0% Authority
Project Managers face a unique set of challenges every day. One of those that comes to mind often is how we, as Project Managers, succeed when we have 100% of the responsibility for the project...
Clinical Research Solutions
Do you need a starting point for a Serialization User Requirement Spec (URS)?
One of the challenges to starting any User Requirement Specification (URS) is to envision a structure which can allow for traceability as the project continues. The attached sample URS is a starting...