Developing An Organizational Roadmap For Post Authorization Safety Studies

With centuries of history and a vast global presence, a top biopharmaceutical company had reached a pivotal point in its ongoing risk management initiative: ensure compliance across its organization.

The firm’s research and development (R&D) branch needed to demonstrate appropriate governance and execution of their current operating model, as well as post-authorization safety studies (PASS) needed to be implemented and managed, while remaining compliant with regulatory, quality, and clinical research requirements.

But with complex processes and legacy documentation heavily entrenched in the organization, identifying next-level opportunities to refine and streamline operations posed a challenge.

To set themselves up for Health Authority Inspection Readiness, the company needed to find a partner to help them analyze the current state of their pharmacovigilance systems and identify opportunities for improvement, as well as implement industry best practices and standards. Download the available case study to find out more.

To learn more about Advarra, visit their Clinical Leader page.