Selected Auditing Services

Lucid performs audits of Common Technical Document (CTD) submittals for accuracy. 

Lucid retrieves all of the original reports that are included in the CTD and verifies 100% of the CTD information using the original reports. 

Any discrepancies are immediately relayed to our client, to allow them as much lead time as possible to rectify any errors. 

Draft Audit Reports are prepared to include the scope, procedure and any observations or findings that were encountered, even if they were corrected before the conclusion of the audit. 

Once all issues have been corrected, Lucid re-verifies the changes made to the CTD to assure that the corrections were made and that other changes were not inadvertently made to the previously correct entries. 

We then issue our Final Audit Report which allows our client to document the full extent of the audit and any problems encountered.

●  The specific example in this summary was a recently prepared CTD for dapsone in a topical gel.  This CTD included information from 53 different studies. 

●  Each entry in the CTD was verified by going back to the original study report.

●  Due to the large size of the CTD, a traditional audit report was not feasible.  Instead, our auditors scanned every page of the CTD that contained an error, and using Adobe^® Acrobat^®, our auditors highlighted the original result and included the correct result in red.  Our auditors then scanned the original study page associated with the CTD error, thus providing an electronic copy of each finding and the source material.

●  By providing a visual indication of the error, the correct value and a copy of the correct result from the original study, our client was able to respond much more quickly to our findings and revise the CTD