A recently published article in Pharmaceutical Executive discusses big pharma’s Quality by Design (QbD) approach to clinical trial management.
April 1, 2013
Improving the quality of clinical trials has emerged as a major strategic activity for Big Pharma, one where efficient management of a demanding set of regulatory requirements—not to mention mounting clinical and patient expectations—can have a positive impact on the bottom line. In the following “leading practices” feature, Pfizer outlines how it has employed a management tool first introduced in the automotive sector to enhance its ability to process reams of data from clinical trials to raise the quality of trial submissions, improve regulatory compliance, and avoid costly rework that ultimately impacts speed to market performance for new drugs.
Pharmaceutical companies are facing growing quality and compliance concerns because of the increasing complexity of clinical trials and substantial changes in the regulatory environment. To protect patient safety and improve the quality of drugs coming to market, Health Authorities are imposing more stringent requirements and higher levels of scrutiny on companies’ compliance with rules and regulations. In 2011, the FDA issued more than twice the number of company warning letters compared to 2005. As a result of greater regulatory hurdles for drug approvals and the need to demonstrate medical differentiation from existing therapies, companies are executing more complex clinical trials in an increasingly cost constrained environment. These challenges have generated an industry-wide imperative to overhaul clinical trial processes in order to improve quality and operational efficiency.