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Article: Strategies For Effective Risk And Capability Assessments When Choosing A Clinical Provider

By Dennis Salotti, COO, The Avoca Group

Clinical Leader – May 1, 2018


Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process. Specifically, ICH recommends that a sponsor maintain oversight of “any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).” Identifying, qualifying, and selecting clinical providers are early and critical steps in the clinical outsourcing process that require attention. This step remains a dysfunctional, decentralized process across the industry, consisting of repetitive, resource-intensive evaluations of providers by sponsors and submissions of information by providers. Just as important is the increased compliance risk for sponsors and CROs associated with missing and inadequate documentation of provider qualification.


Current Qualification Landscape

To understand how sponsors were addressing ICH E6 (R2), Avoca conducted research in 2017 in which sponsors reported a focus on risk management as one strategy, by thinking about risk-based approaches to all trial-related processes, including provider qualification and oversight. In addition to a greater focus on oversight itself, companies also described formalization of processes and tools to help address inconsistent qualification processes and inadequate documentation. When an inspection occurs, it’s important to be able to recreate the story of how selection decisions were made, how the provider was qualified, and how that continues to the oversight plan…

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