Clinical

Today, more and more companies are looking to Clinical Trial Management System (CTMS) and Clinical Data Management System (CDMS) applications to streamline their clinical development operations. When selected and implemented properly, CTMS and CDMS can help users more efficiently and effectively manage multiple trials around the world.

Clinical systems not only allows for the tracking of activities and results with access to real-time information, they can also eliminate the need for ad hoc systems, one-off spreadsheets, and individual approaches to trial and data management. In short, they can enable efficiencies that just weren't possible before.

USDM Life Sciences' clinical system implementation and validation practice focuses on rapid deployment, improved quality and reduced / risk-based validations for all of our engagements. We achieve this through:

  • Experience – a decade of clinical system installation and validation projects.
  • Risk-based approach to validation – a tried and tested method where the focus of the validation is on critical functions and modules that impact compliance data.  All other functions that indirectly affect compliance data are minimally tested.  This is documented in a detailed Risk Assessment.
  • Validation Accelerator Packs (VAPs) for most standard lab systems.  These VAPs are a complete set of content-rich validation document templates for the system based on common, core requirements for life science companies.

The VAP difference:

Each VAP lists requirements and tests for core and common system functionality and can be leveraged to build the validation documentation suite.  The USDM VAPs can decrease both validation time and validation costs by 50%, as well as provide for faster implementation time and better system performance.

Among the common functionality (modules) covered in our clinical systems VAPs are:

  • System access and security
  • Electronic signatures
  • Audit trails
  • Reports
  • Clinical Study Management
  • Clinical Site Management
  • Document Tracking
  • Subject Management
  • Study portals (Sharepoint based)
  • Calculations
  • Reporting
  • Printing

USDM Life Sciences supports the following Clinical applications:

  • Oracle Clinical and Remote Data Capture (EDC)
  • Siebel - CTMS
  • Extedo eCTD Manager Suite

USDM Life Sciences works closely with its partners and vendors to identify upcoming patches and updates, and provides a full maintenance program for our Clinical Systems VAP clients. Recommendations for required testing are made to ensure our clients an effective, efficient validation maintenance process.

USDM Life Sciences has a dedicated, experienced validation team that can customize the VAP templates and provide best practice consulting on regulatory compliance. 

Equipped with over 10 years of experience and specialization in regulated business processes, our skilled team of Clinical Systems validation professionals can provide your organization with innovative and streamlined alternatives to industry standards.

USDM Life Sciences has been successful across many Clinical Systems validation projects 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.

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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