How to cut the time and cost of RFIs and Vendor Qualification
– A Webinar for all Clinical Trial Service Providers –
Open PDF of slides
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Questions and Answers:
Usually it takes 30 days or more to complete an assessment and address issues. What is it reduced to using the digilent platform?
Time is saved as RFI information for each service provider is held within the Platform, so sponsors don’t need to wait for it to be completed from scratch.
Is the platform validated in anyway per GAMP5 etc? Did you ever get sponsors and vendors auditing Diligent Pharma?
We do not certify our platform to such standards as GAMP 5 because we are not under a regulatory obligation to do so. The Diligent Qualification Platform is used to help sponsors to qualify vendors for studies, it is not a part of the infrastructure of studies themselves. Sponsors routinely audit us in their due diligence around engaging vendors.