As of Friday, January 27, 2023 WorldCare Clinical, LLC is pleased to announce that they have successfully passed an FDA inspection showcasing their expertise in handling imaging data with integrity.
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“I am pleased that we successfully facilitated an FDA inspection in support of a sponsor’s clinical program and NDA submission,” said Jim Primerano, CEO. “In our most recent inspection, our team was able to demonstrate the rigor of our QMS and overall performance, resulting in no observations.”
BOSTON (PRWEB)
March 10, 2023
WorldCare Clinical is pleased to announce that as of Friday, January 27, 2023, they have successfully passed an FDA inspection in support of a sponsor’s NDA submission. The goal of the inspection was to verify the charter requirements were followed to observe the reader blinding, training, selection, and monitoring standards and that the system generated subject assessments matched with the FDA’s database for critical data points measuring eligibility and efficacy.
The auditor was pleased to see the high volume of records presented readily and complimented the answers provided by the WorldCare Clinical team. Furthermore, the auditor expressed that it demonstrated our expertise in handling imaging data with integrity, and no 483s were issued due to non-conformance.
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