Reduces Study Startup Time and Database Lock Time More than 60%

A global pharmaceutical company with $16B in revenue was plagued by increasingly steep costs associated with inefficient clinical study practices. USDM executed implementation of a managed service solution to support Clinical Data Management (CDM) for myriad systems.


The Situation

  • Client 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.
  • Clinical Data Management needed a turn-key solution that would reduce the effort required by staff to support study start up UAT of these systems.
  • Additionally, the client wanted to reduce the impact of additional resources onsite, and have access to a pre-trained pool of candidates available as needed to support peak periods.

The Solution

The USDM Team was engaged for 3 years to provide a managed service solution to support Clinical Data Management (CDM) for EDC/IRT/EPRO UAT.

USDM assigned a team of client approved and trained consultants with client provided laptops that were available to support testing.

Monthly planning meeting allocated resources and planned for upcoming new studies and changes. Emergency changes were also accommodated.

Offsite documentation and onsite test execution.

Metrics were monitored and reported to leadership.
  • The scope of the work included: User Acceptance Testing, Change Control and Validation of Standards Library. This included:
  • 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 start-up and changes support for EDC, ePRO and IRT.

66% Reduced Study Startup Time

  • EDC UAT saved $10,000 per study
  • 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 to 14 days • Process Improvement (DM Testing)
  • Savings for EDC UAT project: $90,683 or 42%
  • Reduced study startup for CDM systems from 3-4 months to 1 month.

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