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Survey Time

For drug developers, the transition from traditional, 100% source document verification (SDV) to risk-based monitoring (RBM) strategies requires a sweeping transformation in clinical trial operations. RBM impacts everything Ė from trial design and data management platforms to the roles and skillsets of clinical project teams. Effective change management can identify barriers to implementing RBM, inform the development of training programmes and guide interventions to overcome obstacles among operations teams.

It has been found that incorporating surveys of clinical trial managers (CTMs) and clinical research associates (CRAs) is an effective way to gauge adoption progress and to refine change management processes.

New Mindset

PPD has conducted more than 150 RBM trials since late 2013. Early experience has shown that implementing risk-based approaches necessitates new ways of thinking and executing trials.

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As Executive Director of AIM at PPD, Nicole Stansbury leads the development and implementation of the organisationís RBM strategy. She holds a Bachelorís degree in Animal Science from Texas A&M University, US.
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Nicole Stansbury
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