Our proprietary Electronic Trial Master File (eTMF) platform provides a simple workflow for users across the globe to submit documents without having to spend time on attribution. Our software is built on the Drug Information Association's Reference Model and is fully compatible with other platforms. DRS staff members have years of experience assisting clients with setting up studies, training and ongoing support of loading clinical data to our platform.
New drug applications are on the rise, presenting new demands at the clinical studies level. Study managers are taking on more responsibilities and the need for properly migrating multi-sourced, multi-type studies into their eTMF regardless of type or complexity is of critical importance. DRS offers best in class solutions to help sponsors and CRO's make sure clinical data is being scanned and entered into eTMF platforms on a timely and efficient basis, allowing for Quality Assurance checks of datasets on a real time basis and certifying results.
From its origins in micrographics to the latest innovations in digital storage, DRS has always offered its clients state-of-the-art archival and retrieval solutions. Collectively these credentials have enabled some of the world's leading pharmaceutical companies and CRO's to enhance the management, storage and retrieval of their vital clinical data and related documents. In a digital economy, data security and integrity is paramount. DRS has over 35 years experience meeting and exceeding clients' needs in this area.
Clinical studies are complex undertakings that involve the processing and organization of massive amounts of data. When mistakes occur, timely identification and response means that problems can be resolved prior to inspections. DRS offers full end-to-end eTMF auditing designed to discover problems with clinical data collection, 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.