ParagonRx and Campbell Alliance, both inVentiv Health companies, are again teaming up to provide a solution to a growing need of pharmaceutical clients.
By integrating the broad REMS expertise of ParagonRx with the organizational development expertise of Campbell Alliance, we are providing services to help clients define the roles, governance, procedures, and metrics for optimal risk management operations.
In the four years since REMS was established by the FDA Amendments Act, many pharmaceutical companies have worked through the growing pains of creating their first REMS programs, establishing REMS compliance measures, and submitting periodic reports to FDA. Many leading companies are creating dedicated risk management roles to serve as a center of excellence for this new discipline, but the process of defining roles, creating SOPs, and documenting governance has proved to be challenging.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.