6 Ways to be Inspection Ready. In Real Time. All the Time.
 
And You Can Use Our System   Or  You Can Use Your Own System!
 

The DRS eTMF System ensures 24/7 eTMF inspection readiness by proactively monitoring studies residing in the eTMF using a risk-based approach. To verify the integrity of collections and overall quality, we strongly recommend ongoing eTMF status audits using either your software or ours. Clients who use DRS eTMF software also benefit from DRS full end-to-end document submissions monitoring designed to uncover collection problems, attribution and filing of the study ensuring that all gaps are resolved prior to inspections.

 

Working in close partnership with clients who utilize their own eTMF system, DRS identifies areas in collecting essential documents. These preventative measures and associated corrective actions help sponsors minimize risks and ensure that auditors are provided a complete, correct, current, and compliant TMF to review. Concluding with a TMF that is inspection ready by monitoring and reporting document collection.

 

1. With eTMF software that ensures accountability and the appropriate handling and archiving of trial master files

Of all the activities surrounding the maintenance of clinical Trial Master File (TMF) documents, when it comes to audit readiness, it all comes down to accountability. In addition, using the DRS eTMF solution in conjunction with the DRS Professional Services Group results in the timely review and processing of all TMF documents. Providing at -a-glance status updates of all documents in the system as well as those missing from the system is an essential tool critical for staying compliant. This is critical in remaining ready for your inspection.

2.With a field-proven process that gathers and attributes study documents with consistent index fields and 'easy to locate' document references.

The process of gathering study documents and identifying those that are missing, incomplete or out of order is an often overlooked aspect of TMF document management. It all starts with a well defined set of guidelines for consistent and 'meaningful' index attributes. The attributes form the basis for generating reports that uncovers duplicate files and incorrect submissions that may be misfiled.

By using the single-source DRS eTMF Portal to manage all paper and electronic submissions, all documents are highly visible for QA review prior to final submission to the eTMF. The DRS eTMF software facilitates the document submission process and enables DRS to maintain a 'current' view of the documents submitted in oder to report to sponsor organizations on the integrity of the filing. This allows DRS/Sponsor to complete refresher training if necessary to correct submission errors early in the process.

3. With a team of DRS service professionals who ensures timely and complete document processing.

The DRS Professional Services staff ensures that all critical TMF documents are processed in a timely and complete manner and in accordance with SOPs. Document processing delays can potentially mask gaps, risking exposure to less than glowing or even failed audits. The DRS Professional Services Group makes certain that TMF document management is done according to each customers service level agreements.

4.With a team of professional audit staff who review your eTMF content within your system software and report on the integrity of the documents in the system.

For any eTMF system you are using, DRS provides an overall Risk Based Assessment of the TMF as to the condition, completeness, and accuracy of the filed documents in the TMF. Access to the system is all we require. The DRS Profesional Services staff will measure the effectiveness of document collection and processes to make sure timely submission of site level documents is being done. We complete the oversight of the quality of the documents and associated metadata to ensure compliance with study instructions.

5.With a full review of the documents filed in the eTMF and reporting on findings and observations.

Using a Risk Based approach to the audit review, DRS will provide reporting on document condition, presence of documents, completeness of the metadata, accuracy of the metadata and identify GAPS requiring mitigation prior to site closing or study completion.

6.With a team of professional audit staff who can assist with remediation of problem areas within the system before the inspection occurs.

The collection of missing or incomplete documents can be very tedious. DRS presents options for mitigation that remains to put the file in Inspection Ready Status and

provides mitigation services with direct contact to sponsor partners for open issue resolution and collection of any outstanding records.

"With DRS eTMF Software and Collection Services our reported trial data from source documents is timely, accurate, complete, and verifiable!

We're always inspection ready.

Who can ask for anything more?"