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Vendor Qualification and Audits
We
maintain a list of vendors that we have pre-qualified for our clients.
We
provide our clients with the audit reports from these audits.
These services are crucial for our start up
clients and for our European clients. When we provide the expertise in
this area it allows our clients to focus on the clinical aspects of their
trials. They can complete one audit of ClinChain, Inc. instead of numerous
audits with individual vendors.
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Initial qualification of a potential vendor
is determined by completing our "Vendor Qualification Questionnaire".
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An "Audit Report" is written & sent
to the vendor to address any outstanding issues.
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Annual audits are performed
to ensure the vendors remain in compliance with cGMPs.
We submit request for proposals (RFP) to the
vendors and review the bids in order to get the most appropriate vendor for the
project and to ensure competitive costs for our clients. As the clinical
drug supply needs vary by project we provide flexibility to address the changing
trial drug requirements.
Contact
us for more information about our Vendor
Auditing and Qualification Services.
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