Services

We provide end to end electronic Trial Master File (e-TMF) solutions and services. With extensive expertise in life sciences industry, working knowledge of leading e-TMF technology, successful implementations of varied e-TMF solutions, and quality resources to address your global e-TMF needs.

The business case for partnering with DBA Systems to address your e-TMF, Archive, and Document management needs.

• • Increased scrutiny of the TMF by regulatory health authorities for ongoing and completed clinical trials
  • Increased volume of outsourcing and complexity of oversight of service provides
  • Fragmented approach for management of clinical study data and limited integration (i.e. eDC, CTMS, Safety, etc.)
• Our extensive e-TMF, Records Management, and Document Management expertise covers:

• Archive storage – We have of dedicated resources that are versed in all aspects of secure storage and physical files management on-site and off-site with complete logistics solution (e.g. boxing, packing, indexing and tracking)
• Scan-on-Demand – Enables you to securely store your paper archives and process requests for individual documents to be retrieved, scanned and delivered
• Collaborative authoring, review, and approval of regulated documents
• • Boost the bottom line –We have the capabilities, certifications and expertise to transfer non-core and expensive fixed costs from your balance sheet and make your practice faster and more effective
  • Eliminate the paper –Efficiently and securely converts paper documents to electronic formats and integrate with your enterprise information management system
  • Centralized risk based QC processes
  • Improved e-TMF completeness and quality
  • Track, audit and control – Our solutions control the flow of information to protect your organization and your patients by making active compliance possible. As regulations change, so does our business to ensure that the right people—and only with the right access can manage your information
  • Increased ability to effect process improvements
  • Inspection readiness by improving ability to support regulatory inspection for ongoing and completed studies
  • Streamline and accelerate submission timelines
  • Focused migration of legacy data