In the News

The Situation: After multiple mergers and acquisitions, a global pharmaceutical company was experiencing suboptimal workflow across Drug Safety. Functional areas, including Discovery PK, General Toxicology, Genetic Toxicology, Development PK and others, were operating independently without cohesive processes, systems or data models. In today’s life sciences R&D environments, however, companies are interested in leveraging studies and having access to information across portfolios. At the same time, this environment is becoming more challenging with the use of specialized partner organizations and the mandate to adhere to standards (e.g., SEND). One client found that the issues stemming from acquisitions coupled with inconsistent technical strategies across Drug Safety were hindering their ability to effectively and efficiently conduct their studies. This drove them to an initiative to develop a harmonized technical strategy that could be leveraged across the spectrum of drug safety studies.