Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|October 14, 2011
ParagonRx and Campbell Alliance Announce REMS Organizational Services
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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.
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