Clinical Research Solutions
EMA Good clinical practice (GCP) inspection procedures
The Good Clinical Practice (GCP) Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections requested by the European Medicines...
Clinical Research Solutions
Why the FDA Should Never Be Your First Inspection
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...
Clinical Research Solutions
Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations
Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
Clinical Research Solutions
FDA to Modify Informed Consent Rules, Seeks Feedback
On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations,...
Clinical Research Solutions
Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
Clinical Research Solutions
Pros and Cons of Working with a CRO
Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory...
Clinical Research Solutions
FDA Announces Voluntary Recall of Drugs Containing Valsartan
On Friday, July 13th, FDA announced the voluntary recall of several drugs containing the active ingredient valsartan. Valsartan is often used to treat serious medical conditions such as high blood...
Clinical Research Solutions
Sterility Concerns Cause Voluntary Recall of Various Products: Potassium Phosphate & Succinylchoine Chloride
On June 15, 2017, Hospira Inc. issued a voluntary recall of a number of its products after finding a microbial growth during a routine simulation of the manufacturing process, which represents the...
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
How Important are Clinical Trials in Today’s World of Regulation?
Eliminating clinical trials would be extremely detrimental to the safety and well-being of people all over the world. On Friday, February 24th, The Washington Post published an article written by...