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Clinical Compliance as a Service


USDM provides turn-key solution that reduces clinical study time and study cost

Learn how USDM delivered a managed service solution to a global pharmaceutical company to support Clinical Data Management (CDM) for myriad systems. No longer is this $16B company plagued by increasingly steep costs associated with inefficient clinical study practices.

The Situation
  • A global pharmaceutical company with $16B in revenue
  • Customer had 40-50 studies per year and was seeking to reduce study time and study costs of User Acceptance Testing (UAT) for their Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Electronic Patient Reports Outcome (ePRO) systems
  • CDM team needed a turn-key solution that would reduce the effort required by staff to support study start-up UAT of these systems
  • The customer also wanted to reduce the impact of additional resources onsite, and have access to a pretrained pool of candidates available on-demand to support peak periods
The Solution
  • USDM was engaged for three years to provide a managed service solution to support CDM for EDC/IRT/ePRO UAT
  • USDM assigned a team of customer approved and trained consultants with customer-provided laptops that were available to support testing
  • Monthly planning meetings allocated resources and planned for upcoming new studies and changes; emergency changes were also accommodated
  • Managed service included off-site documentation and on-site test execution.
  • Ongoing KPIs were monitored and reported to leadership
  • The scope of the work included:
    • User Acceptance Testing, Change Control and Validation of Standards Library
    • Harmonization/Standardization Phase to validate core IRT system and create a validated EDC library of standardized case report forms and edit checks to be used across multiple studies
    • Ongoing study startup and changes support for EDC, ePRO and IRT

Efficiencies created:

  • Reduced average EDC UAT time from 110 hours to 24 hours
  • IRT UAT reduced from 5-10 days to 1-2 days
  • Reduced Database lock time from 40 days to 14 days
  • Reduced study startup for CDM systems from 3-4 months to 1 month

The Results

  • Reduced Study Startup Time​
  • $10,000 saved per study with EDC UAT​
  • $90,683 total savings for EDC UAT project


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