Rethinking Biometrics Resourcing in Modern Clinical Trials
Rethinking biometrics as a strategic function to improve consistency, scalability, and clinical trial performance.
FDA Clarifies its Definition of "Convenience Kit"
On January 4, 2016, the FDA published a draft guidance entitled, “Unique Device Identification: Convenience Kits.” The draft guidance comes after the Agency’s 2013 final rule that established a...
Obtaining IND-Related Feedback from FDA
What to do if you experience delays in obtaining IND-related feedback from the FDA: In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations...
Risk-Averse Schedule for Project Management
Is your project schedule ready to pass the Project Management Institute’s (PMI) "litmus test"? Not sure? Well, the Project Management Team at ProPharma is here to lend a helping hand. Below are some...
Regulatory Sciences
The FDA’s Enforcement of Section 503B of the Federal Food, Drug, and Cosmetic Act
The FDA publishes weekly enforcement reports highlighting drugs that have been recalled during the previous week. Over the past several months these reports have been littered with hundreds of...
Operational Qualifications 'Worst Case' Conditions
A common principle in Operational Qualification (OQ) studies is to challenge processes under worst case conditions. A "worst case" condition or set of conditions are generally those parameters...
Quality & Compliance
Project Bullying
Believe it or not, project bullying in the workplace does exist. It is not a threat only at schools and on playgrounds. Project bullying can come for any source including the Project Manager, the...
Clinical Research Solutions
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
Formal Meetings with the FDA Regarding Biosimilars: What’s Changed?
Recently, biosimilars have made a definite appearance on the FDA’s radar, an expected result after the first biosimilar product gained FDA approval in March and the FDA’s release of four final...
There’s an App for That: FDA Launches Orange Book Express App
On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA. What is the Orange Book? The Drug Price Competition and Patent...
Regulatory Sciences
Draft Guidance for Microbial Vectors Used for Gene Therapy Outlines FDA Safety Concerns
Issues for Sponsors with INDs and CMC concerns FDA recently released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy” as a supplemental guidance to “Guidance...
Medical Information Outsourcing Models
In the space of a few years, Medical Information outsourcing has moved from being a last resort to become a core part of the service delivery strategy for most pharmaceutical companies. The speed of...
Which Is Best? Regression versus Control Charting
I was recently asked to review a report summarizing the historic performance of a pharmaceutical process. The report consisted of the usual data tables and charts, but one thing caught my eye: data...
Clinical Research Solutions
The Role of Quality for Commissioning Success
The commissioning process is defined as "a quality-focused process for enhancing the delivery of a project. The process focuses upon verifying and documenting that all of the commissioned systems and...
FDA Investigates Risk of Off-Label Tramadol Use in Children
FDA is investigating the use of tramadol, a narcotic-like pain reliever, in children aged 17 years and younger after learning of the “rare but serious” risk of slowed or difficult breathing....
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...
