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R2 Implementation and CRO Oversight Case Study

Our client, a large global biopharmaceutical company had recently merged with another similar company. The QA department of the resulting company was met with the task of both integrating two quality management systems as well as preparing for ICH E6 (R2). To add further complexity to their situation, our client was also looking to streamline the number of strategic…

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Advance Clinical RBM Implementation

Our client, Advanced Clinical a successful, forward looking CRO who were seeing increasing demand from sponsors to offer quality oversight and central monitoring in accordance with the incoming ICH E6 (R2) guidance. Advanced Clinical wanted to ensure they had both the processes and technology needed to be able to offer and articulate this capability as part of any future…

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Large Pharma RBM Implementation

Our client had strong ambitions to implement both risk-based monitoring (RBM) systems and processes across the entire global organization by the end of 2015. They had chosen a system to adapt to their needs and planned to work to the TransCelerate key risk indicators (KRIs). They needed support in developing the technology to meet their needs, needed guidance on…

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