Vendor Oversight: Not a New Normal, Just an Interim Normal

Posted by Ann Conner on Jun 23, 2020 9:20:16 AM
Ann Conner
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Given our recently-modified approach to executing clinical trials due to the COVID-19 pandemic, it is critical that we update our vendor oversight approach, ask key questions of our vendors, and modify our strategy based on the answers to these questions. Harbor Clinical has the experience, expertise, and plan to assist you in adapting your vendor oversight quickly and effectively.

Vendor-Provided Operating Plans

We should be reviewing pre-pandemic oversight plans and evaluating whether they are still applicable. During the early phase of the pandemic, most vendors sent out details of how they are managing during the pandemic. Were these changes evaluated from an oversight perspective? For example, if a CRO is now performing remote monitoring visits, was any diligence documented regarding how remote monitoring will be done, how source data would be provided and secured for monitors to review remotely, and how potential PHI data breaches would be handled given this new paradigm? Answering these questions is the first step in adapting to the interim normal.

Assessing Vendors’ Plans

For lab vendors, in certain countries sample shipments have been delayed during the pandemic due to cancelled flights and export restrictions.  The lab vendor may have provided solutions and we need to ask: How have these solutions been vetted and assessed to ensure equivalency to the pre-pandemic approach? While the vendor may have provided a solution to address one problem, the proposed solution should be explored to predict and prevent downstream effects.

Business Continuity and Data Security

Have vendors updated and tested their Business Continuity plans during the pandemic and have these test results been reviewed?  With many staff members working from home, how has COVID-19 impacted the security of trial data as it potentially moves from a secure office environment to vendor employees home-based networks.  Has the vendor provided information to demonstrate data security equivalency as employees work from home? 

Harbor Clinical: Navigating the Interim Normal

Certainly, there are many more vendor examples and scenarios to be evaluated during the pandemic and Harbor Clinical can help support you in assessing these by performing a full COVID-19 Vendor Oversight assessment, addressing deficiencies, and supporting updates to these plans.  

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Harbor Clinical’s Vendor Oversight practice is the best way to ensure your teams are ensuring proper vendor oversight. Click this big blue button to let our team know you'd like to talk about this key issue.

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Topics: clinical trial strategic planning, clinical trial consulting, fda, inspection readiness, clinical trial inspection

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