The solution will ‘hand-hold’ companies through the process of performing a protocol risk assessment and developing resulting quality risk management plan.
Following a long-standing working relationship between Triumph Research Intelligence (TRI) and the Metrics Champion Consortium (MCC), TRI will make MCC’s Risk Assessment and Mitigation Management Tool (RAMMT) available as part of the risk assessment and management module in its OPRA Risk-Based Monitoring and Quality Management platform. The OPRA solution will ‘hand-hold’ companies through the process of performing a protocol risk assessment and developing resulting quality risk management plan in a centrally accessible, cloud based application, and provide the guidance which comes from the MCC’s RAMMT content at the same time.
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.