Inspection readiness always starts, of course, with a proven, robust application. And
DRS eTMF is just that! A secure (HTTPS) web-based, Software as a Service (SaaS)
solution, fully validated and easily configured to each study's unique requirements.
Clinical study stakeholders have long embraced eTMF technology for its compliant collection benefits, filing and retrieval
of essential study documents capabilities. But few are leveraging the eTMF to change their inspection readiness strategy into
one that is proactive, preventative and guarantees that best practices are followed. The DRS Audit Team uses the TMF documents'
metadata to periodically perform this essential business and compliance service for its clients. The Team also utilizes Risk-Based
Monitoring to make certain document collection remains accurate and on track throughout the course of the study.
The DRS eTMF application, for example, was not only designed and developed using the risk-based approach, it also adds a
professional service team for indexing and attributing records to predict and avoid as many potential errors as possible.
Proactive monitoring of the TMF is a role we take very seriously.
Working in partnership with our clients in a risked-based review, we identify areas in collecting essential documents that
allow sponsors to minimize risks by proactively taking corrective action; ensuring that sponsor organizations are maintaining a
complete, correct, current, and compliant TMF and conclude with a TMF that is inspection ready by monitoring document collection
Multiple contributors, departments, and companies are the document creators but a complete and accurate Good Order Document Plan is
required. Each contributor must be mindful that submitted documents must be timely but also complete and accurate. Monitoring with
the DRS TMF Professional Services staff can verify that this challenge and responsibility is met and risk of non-compliance is minimized:
• Submission performance vs. milestones
• Quality Failures caused by missing or incomplete documents ro metadata
• Correcting inaccurate documents
• Maintaining consistent and accurate metadata associated with each document
• Assisting sponsors with remediation, reporting and collection
This, along with a 30 year history in records data collection, is the foundation on which the DRS inspection ready products and services
is built. Our focus is on the success of our clients' clinical studies and our goal is to help achieve error free TMF management throughout
In the absence of DRS software and its built-in safeguards, sponsors are tasked with maintaining a TMF that is free of regulatory inspection
red flags. We offer the next best thing through our monitoring service that will keep your current software under constant surveillance with
our TMF Audit Services.
Auditing the records after the study has been completed is an ineffective way to find missing records or identify documents that are not
properly attributed. In 'drop and drag' systems, records are often deposited in the wrong folders and may be lost forever.
One of the most serious concerns is the attribution of study records as they are being collected. We have all been part of studies
when an audit is conducted and it appears that there have been an absence of common rules used in the collection and indexing of records.
Unfortunately, these tools are not always applied proactively throughout the study and human error comes into play when documents are submitted.
It is the typical problem of missing, misfiled or duplicate records that can become a source of frustration for Regulatory Authorities during
inspections. They want to audit the conduct of the study, not the quality of the TMF content. Quite often, the quality of the TMF is a matter
of training and using consistent methods when collecting documents and submitting them to the system. If this ongoing oversight cannot be conducted
by CRO partners using defined attribution naming conventions, then the responsibility falls on the shoulders of the sponsor to identify gaps
and remediate them as soon as possible to avoid further dealys and inaccurate collection. This is not something that anyone wants to find out at
the end of the study or during an inspection.
DRS provides the business process expertise, involvement, documentation, and participation required for a comprehensive TMF Audit . 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. DRS reviews the TMF completeness, ability to locate essential study documents easily, and quality
of the overall TMF.
• DRS reduces the amount of internal sponsor staff required to complete a full QC check of the study
• DRS presents findings as to status and summarizes deficiencies as to risk during an inspection
• DRS reviews the performance of collection and document submitters and the integrity of the document filing and attribution
• 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
"Last March, we asked DRS to validate our TMF just prior to an FDA inspection.
Their auditors uncovered a number of overlooked, citable infractions and methodically cleaned them up.
Thanks to DRS, we passed the inspection.
We are now running DRS eTMF software as well, totally safe and secure with its built-in safeguards."
in real time... all the time!