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.
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.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.