Clinical Research Solutions
Transformational Leadership: Part II
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...
Clinical Research Solutions
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Here I provide some key summaries and considerations relative to FDA’s draft guidance that was submitted for review and comment in June 2017.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...
Clinical Research Solutions
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 implement and manage compliant and risk-based approaches to aseptic...
Clinical Research Solutions
What Should Be on Your Clinical Trial Investigator Site Audit Checklist?
You live and operate in a regulated industry. Obviously, it’s crucial that you stay in compliance during your clinical trials. That’s because failure to do so has enormous and expensive consequences....
Clinical Research Solutions
How to Write an Effective Quality Investigation Report
In 2016, the FDA issued hundreds of 483 observations across the Drug and Device industries for failing to thoroughly review or investigate issues. This topic consistently hits the top five most...
Clinical Research Solutions
Should Data Integrity Detection be a Part of Routine cGMP Training Programs?
The FDA’s focus on data integrity in recent years has proven that it remains an industry issue. The focus has resulted in significantly increased issuance rates of 483 observations, warning letters,...
Clinical Research Solutions
Data Integrity 101: Is your data compliant?
Data integrity has recently been in the agency spotlight. In part because of the draft data integrity guidance issued April 2016, but primarily due to an increased number of inspection findings...
Clinical Research Solutions
Clinical Quality Systems & the Outsourced Model
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Clinical Research Solutions
FDA’s Most Frequent 483 Observations for 2016: A Reflection of Industry’s Compliance
At the beginning of each year, the US FDA posts the previous year’s Form 483 observation metrics issued by each product center. Image Source: FDA I find that reviewing these metrics provides a...
Clinical Research Solutions
The Benefits of Process Characterization in Process Development
The desire for a robust and repeatable manufacturing process is shared by every organization that has a therapy or product in development and the only way to demonstrate that this desired state has...
Regulatory Sciences
Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans
On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled "Pediatric Study Plans: Content of and Process for Submitting...
Clinical Research Solutions
Understanding the 21st Century Cures Act: Part I
The recent passage of the 21st Century Cures Act (passed December 13, 2016) marks a significant milestone for medical device and drug development. I recently attended a meeting held by the Food and...
#5: How to Comply with the Pediatric Research Equity Act
On September 7, 2005, FDA announced the availability of a draft guidance, entitled "How to Comply with the Pediatric Research Equity Act," providing sponsors with a number of recommendations...
Quality & Compliance
The Investigation Best Practices to Avoid FDA 483 Observations
For a number of years, discrepancy and failure investigations within the pharmaceutical industry have been populating the Top 3 of a Food and Drug Administration (FDA) Observation list....
Clinical Research Solutions
#10: Investigator Responsibilities – Protecting the Rights, Safety, & Welfare of Study Subjects
In October 2009, the FDA issued a guidance document regarding its expectations for investigators during the conduct of clinical investigations. The guidance, entitled Investigator...
Clinical Research Solutions
Top Ten FDA Guidance Documents That You Should Know
There are a number of laws, regulations, and guidance documents ruling the pharmaceutical and biotechnology industries. Laws are passed by Congress and must be followed by the FDA. The Agency then...