In a period of unprecedented change, regulatory and operational drivers are transforming the clinical trial landscape. Not only are regulators gearing up for more frequent and intensive unannounced compliance audits, but they are changing the focus of their reviews. They seek risk-based compliance approaches versus "check-the-box" procedures, and the application of high compliance standards across a company's global trials.
PricewaterhouseCoopers’ pharmaceutical, quality improvement and regulatory affairs professionals understand the complexity surrounding Good Clinical Practice compliance and performance improvement. We work with our clients to develop optimal compliance and change management plans that address both today’s demands and tomorrow’s expectations.
Our suite of services in the clinical compliance area combines PricewaterhouseCoopers's strong compliance risk assessment and management skills with a firm understanding and deep practical experience of the application of Good Clinical Practices to the development of pharmaceutical products. Rather than providing a generic approach, we offer customised solutions for the efficient design and implementation of a robust compliance process, tailored to your company's unique needs.