ParagonRx and Campbell Alliance Announce REMS Organizational Services
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.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
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.
Patient Engagement Platform Checklist
November 22nd 2024Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes. We put together this helpful checklist of key features to look out for when choosing a platform for your study.
