Clinical Quality Systems

Our Clinical Quality Systems professionals provide quality, compliance and maintenance support and management to our client’s with existing clinical systems, new clinical systems and/or the integration of both. Our Clinical Quality Systems experts focus on rapid deployment, improved quality and reduced / risk-based validations and implementations for all of our engagements. We achieve this through:

Experience – over a decade of clinical system installation and validation projects. USDM Life Sciences has successfully implemented Clinical Systems around the globe and our best-in-class validation services coupled with proven and effective methodologies can give your organization the competitive advantage it needs to thrive in today's regulated environment.

Risk-based approach to validation – a tried and tested method where the focus of the validation is on critical functions and modules that impact regulated data.

Validation Accelerator Packs (VAPs) – USDM has created VAPs which are a complete set of content-rich validation document templates for the system based on common, core requirements for life science companies.

Existing clinical systems require continual maintenance in change control and validation in order to remain in compliance with regulatory mandates. Our Quality Systems experts will evaluate your current systems and recommend processes and steps to bring the systems into full compliance and then provide a plan to maintain a superior level of continual compliance for the life of the system.

New clinical systems require several key processes in order to ensure compliance, productivity and a return on investment. In these cases, our Quality Systems experts will audit and evaluate potential system vendors and offer recommendations on systems and vendors that best suit our client’s needs, goals and resources. Once a system is chosen, we will write all necessary requirement, configuration and validation documentation and execute the compliant implementation of our client’s clinical system. Finally, as in our existing clinical system offerings, our experts will create processes for the complaint use and maintenance of the newly implanted systems.

Clinical systems often need to share information when systems are upgraded with new technology or replaced. In these cases, USDM’s Quality System professionals will plan, document, validate and execute compliant processes to ensure the integrity, quality and accuracy of transferred or integrated information.

Quality Systems Services:

  • Vendor/System Evaluations, Selection and Oversight
  • System Design, Validation, Implementation, Integration, Testing and Maintenance for:
    • eTMF (electronic Trial Master File)
    • CTMS (Clinical Trial Management System)
    • CDW (Clinical Data Warehouse)
    • eDC (electronic Data Capture)
    • IRT (Interactive Response Technology)
    • eCTD (electronic Common Technical Document)
    • ePRO (electronic Patient Reported Outcomes)
    • eDMS (electronic Document Management System)
    • Safety (Safety Database)
    • Secure Data Server
  • SOP Development