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Digital Transformation in Life Sciences: The Importance of Data Strategy
What is Digital Transformation?
While there are many different definitions of digital transformation in life sciences, the core concepts they all have in common are digital technology and creating new, or modifying existing, ways of working. The underlying business driver is that digital...
Finding a Roadmap to Approval - Hint: You Can't Pick One Up at the FDA
Earning FDA approval for your drug program is a journey. A misstep at any point of that journey could jeopardize your chance at getting your drug approved. That’s why it’s so important to have a...
FDA's Top 483 Observations for 2017: A Reflection of Industry's Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. I find that reviewing these metrics provides a valuable...
FDA Takes Steps to Improve Efficiency of Global Pharmaceutical Manufacturing Inspections
On Tuesday, October 31st, the FDA announced that it will begin allowing eight European drug regulatory authorities to conduct inspections of manufacturing facilities and determine whether or not they...
FDA Launches New & Improved Adverse Event Database for Drugs & Biologics
Last month, the FDA launched a new tool that allows users to search for data on the adverse events associated with drug or biological products, which was added as a dashboard to FDA’s Adverse Event...
Last week, I introduced a two-part series on transformation leadership. We defined transformational leadership, explored the concept, and discussed the benefits of adopting this approach. Well, now...
Selecting the right contract research organization (CRO) is one of the most important decisions you, as a sponsor, must make. That’s because CROs can improve efficiency and increase productivity,...
A couple of years ago, an organization asked me to present to their Leadership Team regarding transformational leadership. They wanted to have a better understanding of what makes an organization...
Summary Considerations: Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers
Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017. If you don’t want to review the entire guidance, here are...
Using a Matrix Approach to Media Fills in Sterile Compounding
Using a Matrix Approach to Media Fills in Sterile Compounding: A survey of FDA Form 483 observations issued to the 503B pharmacy industry reveals that outsourcing compounders are struggling to...
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...
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...
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...
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
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...