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Selected Project Summaries GLP - Contract Laboratory Oversight Our client sent our auditors to a contract laboratory to perform a full audit of the labs systems and documentation. In addition, we were asked to fully audit all of the laboratory printouts for the analyses of study samples. GLP - Observation of Laboratory Analysis Some of our clients request an auditor to be present during every stage of analysis for critical samples. Our auditors directly observe every stage of sample preparation and analysis and provide independent verification of method compliance and technical proficiency of the analyst. We were tasked to perform an audit of the compliance of the stability testing program for a large study. We compared the work performed to the requirements and also checked the accuracy of the results by recalculating 100% of the test results. We were tasked to perform a complete audit to assure the accuracy and completeness of the batch record, and ancillary documentation in preparation for an FDA audit. GCP - Non-Clinical Study Observation One client has a long history with a non-clinical testing facility for a 3-month study. We were assigned a study and asked to directly observe all study-related activities. That included the project set-up, the administration of doses, all time point collections and the compilation of the report. In addition to providing a direct assessment of the study observed, the client also used the information to make inferences about the accuracy and compliance of their contractor on previous studies that were not directly observed. The selected example details our audit to determine whether the data entry was performed correctly for a large study. Over 250,000 entries were included in the audit for a study that was key to the success of our client. Our audits compared 100% of the database entries to the original case report forms. QA Toxicokinetic/Pharmacokinetic Report Review We routinely perform accuracy reviews for TK/PK reports for various clients. Our primary focus is on the accuracy of the report. We perform recalculations on 100% of all parameters and confirm the report accurately summarizes the results. QA - Common Technical Document Review We perform accuracy reviews of CTDs. We verify 100% of the information in the report by referencing the raw data to confirm the CTD report is 100% accurate. |
"We have used Lucid Solutions to support a variety of our projects. They provide us with excellent quality and accurate audit reports delivered on time. We plan to continue to use their services for our development programs." Elyse Wolff Vice-President R&D Project Planning and Management QLT USA, Inc.
"Our Project has always been very data intensive and our largest challenge has been understanding the usability and defensability of the analytical data and proving that our laboratories remained compliant. Lucid allowed us to manage the data and gauge our project's compliance. They also helped our processing and reporting by providing auditors that were technically very proficient." David Strand Project Manager ER Group Federal Subcontractor
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