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DRS has provided a full complement of professional
services and software solutions to the clinical drug research market for 38 years.

In our partnerships with sponsor organizations and their CROs, we support a variety of study requirements through TMF document processing services, study transfers and archiving, and the worldwide deployment of our DRS eTMF.

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ABOUT
Founded thirty-eight years ago, DRS continues to build on our industry reputation for excellence in support of worldwide clinical trials.

  • DRS offers a robust electronic trial master file (eTMF) that can be implemented in a condensed timeline along with multiple custom file structures. The eTMF platform also contains an archiving module for long term storage to meet various regulatory requirements.

  • We proactively work to ensure success in trial management by adhering to good document practice (GDP) guidelines, providing ongoing error reporting, and facilitating timely mitigation of document issues.

  • Sponsors and CROs no longer need to shoulder the responsibility for oversight of the daily document submissions. Proper handling of the study documents by DRS means fewer errors in your study library and higher grades for overall regulatory compliance.
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eTMF Software
Managing a clinical trial and the essential TMF document inventory can be a difficult task, unless you begin the journey with the proper eTMF platform and support services.

  • The DRS eTMF software is built to accommodate a variety of file structure formats and allows for streamlined integration with the widely accepted TMF Reference Model. The small footprint of the application enables us to deploy the system in a condensed timeline and additional studies can be activated seamlessly.

  • The DRS eTMF platform provides a simple workflow for users across the globe to submit documents without requiring time-consuming attribution of the records.

  • DRS analysts conduct document reviews and send automated messages to any document submitter if good document practices (GDP) and quality standards are not met. This promotes timely correction of errors.

  • The DRS team has a high level of experience in assisting clients with study eTMF set-up, user training and access management, and ongoing system support.
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TMF ARCHIVE VIEWER
DRS Corporation's eTMF Archive Viewer can help consolidate your closed/older studies to one central location for easy access.

Clinical study documentation can be maintained in various formats throughout the life of a trial. This can create problems when it comes time to research, reactivate, or archive a study in a system or software that may no longer be supported.

The DRS eTMF Archive Viewer module provides the following benefits:
  • A study folder structure (TMF Reference Model or otherwise) can be archived and directly accessible to required users from our Tier 3+ data center.

  • Perform searches using file naming conventions, reference numbers, or other key identifiers.

  • Assign read-only access to a study regardless of the original software platform used to store the data during the study.

  • DRS can manage any of your current archive studies if you are not CERTAIN that they are all accessible and residing in a format that is discoverable and regulatory compliant for long term retention.
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DOCUMENT QUALITY CONTROL
New drug applications are on the rise, which presents new demands at the clinical study operational level. The proactive monitoring of the documents and timely processing by DRS analysts can help!

  • TMF document misfiles and the potential for backlog in QC (attribution) of your study documents can create issues with the study integrity. It is vital that you're not surprised by poor document management at the end of the study.

  • DRS offers best in class solutions to help sponsors and CROs guarantee that clinical documents are being submitted into the eTMF on a timely basis with a high degree of accuracy.

  • DRS processing services reduce errors, improve reporting, and stimulate a higher likelihood of regulatory compliance.

  • Our eTMF Professional Services team provides the study integrity you need to confidently monitor your inspection readiness.
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STUDY OVERSIGHT
The DRS TMF Oversight Report is a compilation of metrics that indicate the overall quality and condition of the eTMF inventory. DRS Clinical Document Analysts will review the metrics and deliver a report that gives sponsors a real-time look at the health of their study.

The benefits of this type of reporting are:

  • Quality - This is a continuing effort to reduce errors and duplicates before the end of the trial.

  • Completeness - Showing gaps that exist so document submitters know what still needs to be sent to the eTMF.

  • Timeliness - With an ongoing review, DRS can assist with the remediation of any document issues within the TMF as the study progresses instead of saving the review until the end.
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INSPECTION READINESS
Clinical studies are complex undertakings that involve the processing and organization of large amounts of data. When mistakes occur, timely identification and response are crucial in ensuring that problems can be resolved prior to inspections.

  • DRS offers full end-to-end eTMF auditing designed to discover problems with clinical data collection, missing documents, metadata attribution, and filings of the study documents.

  • Regardless of the 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.
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ELECTRONIC TRANSFERS
DRS has a long-standing reputation for transferring studies from various platforms into a sponsor system or the DRS eTMF. Electronic transfers of clinical studies can be required for multiple reasons - all of which are important to the success of your TMF.

  • CRO Offload - It is typical for a CRO to turn over a study to the sponsor organization upon completion. This requires a diligent transfer from one source to another and long-term archiving.

  • Sponsor Acquisition - A sponsor acquisition of a study TMF asset is most important, as the transfer of the study is generally a requirement of the Asset Purchase Agreement, and must be reconciled.

  • Study migration to your common platform also provides a means of conducting an audit review of the content for missing items that need to be recovered.

  • As part of the transfer, DRS supplies the necessary migration documentation to verify the integrity of the deliverable.
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PAPER TRANSFERS
DRS has been scanning critical document projects for 35+ years and we are a trusted partner for managing the most difficult initiatives. It doesn't have to be your headache!

The scanning of clinical paper files gives sponsors the opportunity to create a fully electronic TMF as well as produce an index to all documents in the binders. Conducting research on the studies is simplified and the task of generating gap reports on the content is more viable for study managers.

  • Quality - DRS follows ALCOA+ guidelines in every step of our process

  • Certification - Following scanning of the paper, we provide a page-by-page comparison to ensure proper quality and proof of the paper record certification.

  • Upload - All scanned electronic documents are uploaded to the sponsor eTMF, or the DRS system platform, and all document attributes/metadata are applied as per sponsor requirements.
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ARCHIVE SERVICES
The DRS TMF Archive Services help consolidate your closed/older studies in one central location for easy access.

Sponsors require studies to be accessible in a supported platform during archiving. If a sponsor partners with multiple CRO's, there is a good chance that they will require maintenance of several platforms to satisfy regulatory requirements for long term archive and retrieval.

DRS has several options for archiving that can meet all necessary sponsor requirements.

  • DRS can migrate and map the closed study into the DRS eTMF or a sponsor eTMF.

  • If a vendor format has been used that cannot be mapped or is no longer supported, DRS transfers the TMF document library, metadata, and audit records into our Archive Viewer module which provides access to your archive inventory.

  • Users can perform searches on a file name and the results are displayed for any record containing the search parameter. Additional searches allow for a query across multiple database fields.
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CONTACT US


phone - 908.687.5636
email - info@drscorp.com
As one of the premier providers in the Life Science industry for 38 years, we welcome your questions and will support any initiatives you may have in your TMF. Trust in DRS !
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