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On March 8, 2016, the FDA announced availability of a revised draft guidance for industry regarding pediatric study plans, entitled "Pediatric Study Plans: Content of and Process for Submitting...
#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On September 7, 2005, FDA announced the availability of a draft guidance, entitled "How to Comply with the Pediatric Research Equity Act," providing sponsors with a number of recommendations...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...
Is Your Laboratory PC Cloned From the Proper Image?
Managing compliance for computerized lab systems includes the PC controlling your qualified instruments. This is an integral audit point that must be maintained to ensure compliance. Ah, but you’re...
Clinical Research Solutions
How critical is the Technology Transfer phase of new drug development?
During the development phase of a new drug, great pains are taken to characterize the molecule and to run a myriad of laboratory and animal tests to determine the product attributes, toxicology...
Clinical Research Solutions
Does Your Training Program Have Traction?
With the spotlight these days on Data Integrity, it may be easy to lose sight of some fundamental Quality Systems. Core Quality Systems include Document Management, Investigation Management, and...
Clinical Research Solutions
How Much Can You Afford NOT to Know?
The Regulatory Guidance embodied by ICHQ8 through (soon to be written) ICHQ12 tells us in no uncertain terms that we must protect the patient across the product lifecycle by assuring quality based on...
Problem Solving: What’s the Best Approach?
Those of you in the pharmaceutical, biotech and medical device industries who encounter process and product problems on a regular basis, you likely grimace when one lands in your lap. There is a...
Clinical Research Solutions
Quick Guide: cGMP for Phase 1 Investigational Drugs
As Phase I clinical trials mark the first time that an investigational new drug is administered to humans, these studies are subject to appropriate current Good Manufacturing Practices (cGMP) in...
Clinical Research Solutions
Does your Quality System stand up to the challenge?
Implementing and maintaining a Quality System is a complex challenge. It is as much as an art as it is a science. A company’s Quality System establishes the framework to manage and maintain...